the comma 2007 2 16.pdfspeakers of german. there is one rule of english comma usage—and it really...

Vol. 16, No. 2, 2007, ISSN 1854-8466.

The comma

The Journal of the European Medical Writers Association

TheWrite StuffVol. 16, No. 2, 2007

43

Cover pictureThe cover picture is a cartoon drawn by Michael Dawes. The cartoon also appears on

page 61 with a caption. The cartoon on page 45 was also drawn by Michael Dawes.

EMWA Executive CommitteePresident:

Julia Forjanic KlapprothTrilogy Writing & Consulting GmbH

Falkensteiner Strasse 77

60322 Frankfurt am Main, Germany

Tel.: (+49) 69 255 39511, Fax.: (+49) 69 255 39499

[email protected]

Vice President & Programme Manager:Helen Baldwin

SciNopsis

Eden Park B, 1 rue Jean Carrara

83600 Fréjus, France

Tel.: (+33) 494 83 90 20, Mobile: (+33) 662 37 91 36

Fax: (+33) 494 83 86 91

[email protected]

Treasurer:Wendy Kingdom

1 Red House Road

East Brent, Highbridge

Somerset, TA9 4RX, UK

Tel: (+44) 1278 769 214, Fax: (+44) 1278 769 214

[email protected]

Secretary:Julia Cooper

PAREXEL International Ltd.

101-105 Oxford Road

Uxbridge, Middlesex, UB8 1LZ, UK

Tel: (+44) 1895 614 403, Fax: (+44) 1895 614 323

[email protected]

Public Relations Officer:Kari Skinningsrud

Limwric as

Leiv Eirikssons gate 8

NO-2004 Lillestrøm, Norway

Tel: (+47) 63800448, Mobile: (+47) 41338765

[email protected]

Website Manager:Shanida Nataraja

Discovery London, Pembroke Building

Kensington Village

Avonmore Road

London W14 8DG, UK

Tel.: (+44) 207 173 4121, Fax.: (+44) 207 173 4001

[email protected]

Education Officer:Stephen de Looze

Accovion GmbH

Helfmann-Park 10,

D-65760 Eschborn (Frankfurt), Germany

Phone: (+49) 6196 7709 312, Fax: : (+49) 6196 7709 114

[email protected]

Journal EditorElise Langdon-Neuner

Baxter BioScience

Wagramer Strasse 17-19

A-1220 Vienna, Austria

Tel.: (+43) 1 20100 2067

Fax.: (+43) 1 20100 525

[email protected]

EMWA Head OfficeIndustriestrasse 31, CH-6300 Zug, Switzerland

Tel: (+41) 41 720 3306, Fax: (+41) 41 720 3308

[email protected]

EMWA website: www.emwa.org

Journal insightsTheWrite Stuff is the official publication of the European Medical

Writers Association. It is issued 4 times a year and aims to provide

EMWA members with relevant, informative and interesting articles and

news addressing issues relating to the broad arena of medical writing.

We are open to contributions from anyone whose ideas can complement

these aims, but opinions expressed in individual articles are those of the

authors and are not necessarily those held by EMWA as an association.

Articles or ideas should be submitted to the Editor-in-Chief (see below)

or another member of the Editorial Board.

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Instructions for contributors• TheWrite Stuff typically publishes articles of 800–2800 words

although longer pieces or those with tables or graphics will be considered.

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The Editorial BoardAssistant Editor Barry DreesCopy editing Judi Proctor

Chris PriestleyJulia Chamova Richard ClarkRosalie RoseUrsula Schoenberg

Columnists Alistair Reeves Karen ShashokAlison McIntoshDiana EpsteinSusanna DodgsonJoeyn FlauausDianthus team

The Journal of the European Medical Writers Association 44

TheWrite Stuff Vol. 16, No. 2, 2007

EMWA 9th

Autumn Meeting1-3 November 2007, Basel

You are invited to the 9th Autumn

EMWA meeting to be held in Basel,

Switzerland from 1 to 3 November

2007 at the Ramada Plaza Basel.

The Autumn conference will again provide members

with further opportunity to continue with their training

in the EMWA professional development programme.

The workshop programme will cover a wide range of

medical writing subjects, including advanced

workshops for experienced writers looking to keep

their knowledge up-to-date or refresh their skills.

Further details and regular updates will soon be

available on the website at www.emwa.org.

Basel is perfectly situated for an Autumn

conference. Centrally located on the border of

Switzerland, Germany and France, it is easily

accessible from all corners of the EU.

The city has the oldest university of the Swiss

Confederation (from 1460), one of the best-preserved

old towns in Europe and more than 30 museums.

Basel is also a seat of the pharmaceutical industry

in Europe and we are hoping to have a speaker

from the European Center of Pharmaceutical

Medicine, which is located in Basel.

So make room in your calendar now and join us inBasel for a day of expanding your medical writinghorizons.

Julia Forjanic KlapprothEMWA President

Don’t be taken in by the theme of this issue. It’s not dulland it’s not innocuous. The comma has a history and it isstill making history.

The comma’s ancient origins go back to the Greeks whenin the third century BC the head librarian of the library ofAlexandria, one Aristophanes of Byzantium, devised a sys-tem of dots (distinctiones) placed at the bottom, middle or topof the line to signify how much breath you needed to take toread a fragment of text out loud [1]. The komma, as it wascalled, was not one of these dots but the term for the shortestpassage denoted by a dot placed mid-level ( · ). Some thou-sands of years later in the 16th century the virgule suspensiva(/), which had emerged in the 13th century and represented apause in text, took a curve and tumbled down to the bottomof the line to become our punctuation mark, the comma.

It’s been there and causing trouble ever since. In her bookMedical English Usage and Abusage, Edith Schwagergives an example of how we can trip up on a comma. Sheparaphrased a citation from the American journalistTheodore M. Bernstein: “In 1873 the Congress enacted atariff bill intending to exempt certain products from pay-ment of duty, including ‘all foreign fruit-plants’ that is,plants imported for the purposes of experimentation, prop-agation, or transplantation. The clerk who copied the billmistakenly used a comma [fruit, plants] instead of ahyphen. Until a new version of the act could be printed, allforeign fruit and plants were lawfully admitted to U.S.ports duty-free”. The resulting loss of revenues to the USAwas more than $2 million.

In an interview with Wolf Blitzer broadcast on CNN on 24th

September 2006 President Bush, asked about the war in Iraq,

said “I like to tell people when the final history is written on

Iraq, it will look like just a comma”. This provoked outrage.

Many people viewed the statement as a dismissal of the deaths

from the war as nothing more than ‘just a comma’ [2]. A salu-

tary cartoon depicting a military graveyard with row upon row

of plain white graves embossed only with a large black

comma captured this view [3].

In ‘The fatal comma’ article in this issue of TWS Richard

Clark refers to a court case currently being fought in the

US which hangs on a comma and could cost the defendant

over $2.13 million. He also gives examples of a comma

that reprieved a prisoner from exile to Siberia and an

attempt to use the absence of a comma by the barrister rep-

resenting Sir Roger Casement, the Irish nationalist hero, to

save his client from hanging for his part in planning the

Dublin Easter Rising of 1916.

The massive success of the Lynne Tullis’ book Eats shootsand leaves is another reason that the comma and punctua-

tion in general should not be ignored. Messing around with

punctuation no longer has the image of a backroom pas-

time indulged by the greying lady editor with her hair tied

back in a bun. You only have to write about these things to

bounce out of the backroom and become rich and famous.

(There’s hope for TWS yet.) Books abound with titles like

Lapsing Into a Comma (by Bill Walsh), Comma Sutra (by

Laurie Rozakis), Commas Are Our Friends (by Joe

Devine), and Comma Sense: A Fun-damental Guide to

Punctuation (by Richard Lederer and John Shore).

So the comma which started life as an indication of where

to take a breath has taken our breath away more than once

in its long history. The North Americans have a reputation

for littering their text with commas. An American writer

and editor confided to me that she had no idea where to put

commas but would generally insert them where she would

take a breath in reading. Bill Walsh admits in his book

mentioned above that the ‘take a breath’ comma is occa-

sionally appropriate when the wording is unwieldy or

when a dramatic pause is desired. He gives the following

example: “Today, Shelley is on duty in what he calls a

“one-man fighting hole” on another battlefield—a Marine

recruiting station in Lexington Park, Md., in St. Mary’s

County—with a mission to persuade young men and

women to enlist, and probably go to war”. The comma

The comma



45

By Elise Langdon-Neuner

From the editor's desk:



From the editor's desk

after enlist introduces a pause effect. The phrase following

it is not a straightforward part of the persuasion; it’s a nec-

essary consequence of the other things he’s persuading

people to do [4].

Usually North American style guides now recommend

using fewer commas rather than more. Most writers and

editors still do not go as far as Gertrude Stein who thought

that we could manage very well without commas. Yet her

texts were clear and demonstrated a mastery in the craft of

writing seldom encountered in medical writing. Mary Ellen

Kerans writes about Stein in this issue of TWS and gives

examples of her penmanship. Ordinary mortals could take

the opportunity to use a full stop rather than ‘and’ or ‘but’

where a comma would otherwise be needed (, and). The test

for this is whether it is indeed possible to divide the sen-

tence into two sentences.

Ursula Schoenberg discusses the cultural differencesbetween English and German comma usage in her article inthis issue of TWS. I edit English text written by nativespeakers of German. There is one rule of English commausage—and it really is a rule—which is often broken bythese authors: a subject should never be separated from itsverb by just one comma. An example of this transgressionis: “The expression vectors harboring the antibody genesused in this study, were constructed at our facility”. Theexpression vectors are left stranded from their verb ‘wereconstructed’. A second comma is needed after ‘genes’ toseparate off what in their articles in this issue of TWSAlistair Reeves calls a commenting clause and ValerieElliston calls an isolating or bracketing comma. Everythingelse that needs to be said about commas I will leave to theexperts. This issue of TWS gives you a series of compre-hensive articles by Alistair Reeves, Valerie Elliston, andRichard Clark. But sometimes experts disagree. If youwant to test your comma prowess after reading these arti-cles try the BCC’s quiz and their game with the scenario“You’ve got a new job, so you’re going to need to knowyour commas for those lists and reports” (both athttp://www.bbc.co.uk/skillswise/words/grammar/punctua-tion/commas/ ). The game might help you when makingnotorious dedications of this nature: “To my parents AynRand and God”. This is an apocryphal book dedicationwhich should have been written “To my parents, Ayn Rand,and God.” to avoid the impression that the person’s parentswere Ayn Rand and God. The example is used to supportthe argument for using a serial comma [5].

If you know all about commas and never err in their usagedo not despair because there is plenty more to read about inthis issue of TWS. One article on clinical trial disclosure isparticularly topical. Special thanks to Kathy Thomas andClaudia Tesch for all their efforts which have made it pos-sible to include the article in this issue of TWS. At the lastminute before the issue was due to be sent to the printersthe International Committee of Medical Journal Editorsmade a statement about clinical trial registration. Theauthors have worked hard to include a commentary on thestatement in their article. An accompanying box drawsattention to the meta-analysis by Steven Nissen and Kathy

Wolsk published in the New England Journal of Medicinewhich has evoked a heated debate about the safety ofrosiglitazone. Data from GlaxoSmithKline’s study resultsdatabase were used for the meta-analysis by these inde-pendent scientists. The report has led to hectic activities byGlaxoSmithKline and the US Federal Drug Agency andshareholders are suing the company for not adequately dis-closing studies it had conducted into rosiglitazone.

Elise [email protected]

References:

1. http://en.wikipedia.org/wiki/Comma_(punctuation)2. http://www.washingtonpost.com/wp-

dyn/content/article/2006/10/04/AR2006100401707.html3. www.anntelnaes.com/images/092606BushCommas.gif4. http://theslot.blogspot.com/2005/03/i-rant-and-rave.html5. http://en.wikipedia.org/wiki/Serial_comma

What’s news at EMWA?

The EMWA Spring Conference, Vienna 2007

Why I enjoy EMWA Springconferencesby Margaret Bray

I always enjoy EMWA Spring confer-

ences and this year’s conference in

Vienna was no exception. This was my

7th Spring conference, and in my view

the best venue we’ve had for a confer-

ence in my time as an EMWA member,

and one of the best in terms of work-

shops, social programme and the spe-

cial focus on medical communications. I’ve never travelled

to Vienna before, and I found it such a welcoming place.

The sun was shining, the atmosphere in the hotel/confer-

ence centre was great and within 5 minutes you were with-

in the majestic environs of the city. Indeed, a highlight of

the week was the tour of some the galleries of the

Kunsthistorisches Museum, prior to our banquet under the

museum’s dome. Built to house the Hapsburg monarchs’

art treasures, we were given a tour of the museum’s collec-

tions of paintings by the great renaissance painters such as

Arcimboldo, Rubens, Titian, Velazquez, Carravagio and

Bruegel, and given a fascinating insight into the history

and techniques behind the paintings.

I participated in three main workshops. Periodic Safety

Update Reports led by Alison Rapley was for credit on the

Advanced Programme. I have written a number of PSURs,

but have received little training and it was good to hear

what Alison had to say. It was also good to attend this

workshop to bring myself up-to-date with new guidelines, > > >



47

What’s news at EMWA?> > >

something I would not necessarily have found out myself.

So thank you Alison! One of the interesting and important

aspects of PSURs is the different safety terminology used

in these reports compared to, for example, clinical study

reports. It’s very useful to be familiar with PSUR terminology

especially when it comes to understanding drug labelling

etc. So, I recommend any writer involved in drug develop-

ment to attend this workshop.

Medical Writing and Observational Studies led by Thomas

Wagner was also part of the Advanced Programme. I’ve

never written an observational study, although I have come

across them from time to time in the course of my work. It

was good to learn to recognise the difference between

observational studies and the standard ‘drug interventional

study’. I also participated in one workshop from the

Foundation Programme, Helen Baldwin’s From Clinical

Study Report to Manuscript. In the course of my work I’m

often requested to write a manuscript from a study report,

and it was good to get some fresh ideas from Helen.

However, workshops aren’t everything at a conference,

and for me the most important aspect is to spend 5 days in

the company of other writers talking and networking,

meeting old colleagues and friends, and meeting new faces.

Whether it’s a round table lunch discussion about patient

information leaflet readability, talking medical communi-

cation over breakfast, discussing freelancing matters over a

drink in the bar, there is always something to talk about. I

rarely travel as part of my freelance business and most of

my work is done via email and telephone from home. I

don’t feel isolated because of this because I have a very full

work and home life. However, for me life as medical writer

would be less inspiring without a conference. So I really

hope to see you in Barcelona next spring so we can com-

municate some more.

Margaret BrayBray’s Medical Writing ServicesKent, [email protected]

Report from the FreelanceBusiness Forum in Viennaby Alison McIntosh

This was the 5th meeting of the EMWA Freelance Businessforum, and we had the largest number of freelance mem-bers attending to date with about 55 attendees—a verygood turnout despite the late hour of the day and the immi-nent prospect of evening walking tours of Vienna insuperbly warm weather. The meeting this year was co-chaired by Alistair Reeves and Sam Hamilton.

Alistair started the meeting by giving us a sneak preview ofthe Freelance Business Survey which is being carried outby EMWA. The survey was last carried out in 2003, so thisnew information will provide a more up to date snapshot ofwhat members are currently charging for their work, aswell as highlighting the types of work EMWA freelancemembers (and a few others who responded) are undertak-ing for clients.

Although the full results of the survey will not be availableuntil the September issue of TWS this year, we were givenan indication of what to expect using the preliminary dataavailable in mid-April. At that time there had been 80respondents (63 in 2003), with the largest group comingfrom the UK followed by Germany, as in 2003. The major-ity were working full time, with key activities being med-ical writing, editing and translation. Most written docu-ments were for the drug approval process, scientific papersand marketing material.

There is still time to take part in the survey, which can becompleted online and takes only a few minutes. Yourresponses are confidential, as there is no way of identifyingwho has responded. As a medical writer, you know: themore people who respond, the more robust the data! Thesurvey is open until 13 July 2007. You can complete the ques-tionnaire by pasting the following link into your browserhttp://www.surveymonkey.com/s.aspx?sm=kLNS3CdA%2bzd24JHK0mE8%2fw%3d%3d. So, please, if you have notyet responded, make sure you do before the deadline!

A second topic for discussion was the possibility of provid-ing templates for legal documents. A show of hands indi-cated that in most countries writers depended on receivingdocumentation regarding confidentiality agreements andcontracts from their clients. These were read very careful-ly and any inappropriate clauses discussed and hopefullyremoved. This was not true in some countries, includingFrance, where some writers had each contract looked overby a lawyer before signing. After some discussion it wasconcluded that it would probably be too difficult to haveappropriate wording suitable for every EU country.However, Sam together with Linda Liem volunteered to puttogether a useful checklist of what needs to be considered incontracts. In addition, a list of general tips for business set upand conduct was suggested as a potentially useful resource.Helen Kulesza and Elaine O’Prey offered to help with com-pilation of this list. This list will be published in theSeptember issue of TWS and on the website.A question is raised at EMWA’s Annual General Meeting in Vienna



What’s news at EMWA?

Further topics of discussion concerned the question of shar-

ing information about late or non-payment, as well as issues

new freelance members need to look out for when begin-

ning. Although a few members had experienced non-pay-

ment from individual clients, it did not appear to be wide-

spread. Late payment was more common, but most free-

lance members reported that payment eventually comes

through without resorting to lawyers. A request was submit-

ted for a bulleted list to be provided on the website concern-

ing “Freelance Pitfalls,” but this would cover only general

concerns and not information about specific clients1.

Thanks to Alistair ([email protected]) and Sam

([email protected]) for organising and

chairing the meeting, and also undertaking the new survey.

And (from Alistair and Sam), thanks to Alison for prepar-

ing this report on the meeting.

If you would like to help Sam with the checklist, she will

be pleased to hear from you. And if you have any ques-

tions, concerns or comments about any of the issues report-

ed here please let us know. Alistair received several

requests for a similar forum at the EMWA Autumn meet-

ing, as it is often easier for freelance colleagues to attend

the shorter meeting, so we will be making sure that the pro-

gramme at future autumn events also includes a Freelance

Business Forum.

Alison McIntoshAAG Medical WritingLoughborough, [email protected]://www.aagmedicalwriting.co.uk

1 Post meeting note: It was suggested that an e-mail list of freelancers was set up to

circulate information. All freelancers would receive the mails and it would be up to

the individual to participate in the e-mail dialogue. This possibility is currently being

explored with EMWA.

The five Nick Thompson Award fellows on the occasion of the presentation of

the fifth award to Marion Hodges in Vienna at the 16th Annual Spring EMWA

Conference. The fellows are (from left to right): Art Gertel, Geoff Hall, Marion

Hodges, Barbara Grossman, and Barry Drees. The Nick Thompson award con-

fers on the recipient lifetime honorary membership in EMWA and is awarded

to EMWA members on the basis of extraordinary contributions and service to

EMWA. It honours the late Nick Thompson, one of the founding members who

played a key role in the establishment of EMWA. Nominations for a Nick

Thompson Award can be made by any EMWA member (other than existing

recipients). The nomination is submitted to the president of EMWA, who, pro-

vided he or she feels that the nomination is not frivolous, then passes it on to a

panel comprising existing Nick Thompson award holders, who discuss the nom-

ination in private. If the panel decides unanimously in favour, the president is

informed and the award is presented at the following spring conference. TWS and

all EMWA members would like to extend hearty congratulations to the newest

Nick Thompson fellow, Marion Hodges, who can be seen below (right) receiving

the award from EMWA’s new president Julia Forjanic Klapproth (left).

Virginia Watson with the bouquet she received at the Spring Conference in

Vienna as a token of EMWA’s gratitude for her hard work and dedication as

Education Officer for the past 2 years and the many years before this that she

contributed to developing EMWA’s Professional Development Programme.

The Photographs on pages 47 and 48 were taken by Crispin Hodges

([email protected])

The decimal comma-pointconundrum Amelia Williamson, intern at Science Editor (the

Council of Science Editors periodical), has been prepar-

ing an article about the style differences in decimal

notation. Most of Europe uses the comma as a decimal

separator, while the United States uses the period. The

article discusses the history of decimal notation and the

style difference as well as potential problems the differ-

ence could pose for writers and editors. The article is

expected to appear in Science Editor in late 2007 or

early 2008.



49

Moral dilemmas Do medical writers face moral dilemmas and if so whatrole does intuition play in resolving them? For a job thathas the image of working in a backroom poring overcomplex data and compiling documents all day, medicalwriters if you go by reports about ghostwriters in thepopular press are faced with an alarming number ofmoral dilemmas on a daily basis….

“Nothing captures human attention more than a moral

dilemma. Whether we are soap opera fanatics or not, we

can’t help sticking our noses in other people’s affairs,

pronouncing our views on right and wrong, justified or

not.” These words introduce the MST (Moral Sense

Test) website [1] created by the psychology department

at Harvard University. The website is part of research the

university is conducting into the role of intuitive respons-

es in ethical reasoning. Visitors to the site are asked to

participate in the research by completing the test.

The tens of thousands of responses that have already

been received show a high degree of consistency regard-

less of the participants’ nationality, ethnicity, religion,

age and sex. Joshua Greene working at Harvard has

shown by functional magnetic resonance imaging that

when people are asked to make a moral judgement about

‘personal’ violations, like pushing a stranger off a foot-

bridge, activity increases in the brain areas associated

with emotions. A similar increase was not seen with

‘impersonal’ actions, like throwing a switch that diverts

a train. His explanation is that it has only recently

become possible to harm other people through remote

rather than personal contact. The evolution of emotional

responses is still lagging behind this development. The

consistency in moral intuitions does not necessarily

make them right. Peter Singer, a professor of biometrics

at Princeton University, suggests on the contrary that we

should be sceptical about relying on our intuitions [2].

Blowing up people with bombs is no better than club-

bing them to death. We should think for ourselves and

not just listen to our intuitions.

Elise Langdon-Neunerlangdoe@baxter .com

References:

1. http://moral.wjh.harvard.edu

2. www.project-syndicate.org/commentary/singer21

(NB: the Project Syndicate website is excellent for anybody interested in

world politics).

MedDRA ‘preferred’ termsFor anyone involved in writing up the findings of clinical

trials for study reports or preparing summary documenta-

tion for market authorisation dossiers, the advent of the

Medical Dictionary for Regulatory Activities (MedDRA;

http://www.meddramsso.com/MSSOWeb/index.htm)

was certainly a great leap forward.

Since clients have been using MedDRA, however, I

have noticed a phenomenon which was not so marked

when they previously used other classification and cod-

ing systems: insisting on using ‘preferred terms’ in the

‘logical’ order they are used when coding with MedDRA

when writing up results, i.e. ‘term’ and then ‘modifier’,

when the actual ‘expected’ word order in English is the

reverse, because most terms are nouns and most modi-

fiers are adjectives.

Good examples are ‘rash’ and ‘dermatitis’, which are

often modified. I can live with ‘rash morbilliform’, ‘rash

maculo-papular’ or ‘dermatitis contact’ in lists in fre-

quency tables, but I think we should make the extra

effort in the accompanying text to supply the reader with

the expected word order, viz ‘morbilliform rash’, ‘mac-

ulo-papular rash’ or ‘contact dermatitis’. Tables are

probably generated from the database where the terms

are stored with the modifier as some sort of subset to the

condition, and it would be an inordinate amount of work

to go through every table switching them around. But

text is a different matter. To me, leaving the modifiers

after the terms is doing a disservice to the reader.

Recently a client insisted on saying ‘One patient devel-

oped hallucination auditory’ and the reason was

‘because this is the order in MedDRA and this is how it

is listed in our tables’. Is there really any likelihood that

the informed reader (and I assume that authority review-

ers can be regarded as such) might think that the ‘audi-

tory hallucinations’ in the text accompanying a table

were different from the ‘hallucination auditory’ listed for

a patient in a table just above, or in a table in the report

appendix? Would you prefer to read ‘Atrioventricular

block first degree was observed in 2 subjects’ or ‘First-

degree atrioventricular block was observed in 2 subjects’?

Am I making a mountain out of a molehill? It would be

interesting to hear what others think about this.

Alistair [email protected]



Call for manuscriptsA special issue of Panace@ asks, “Should the entire

protocol of every clinical trial be translated into the

researchers’ local language?”

In Spain the time to approval for a multicenter clinical

trial was shortened substantially by skipping some steps

in the approval process. The Spanish drug regulatory

agency and co-ordinating centre’s clinical trials ethics

committee agreed to the abbreviated process because the

trial (of an avian flu vaccine) was considered a high pub-

lic health priority [Dal-Ré R, García-Corbeira P,

Morejón E. ¿Cuál es el tiempo mínimo necesario para

iniciar un ensayo clínico multicéntrico en España?

Medicina Clínica (Barc) 2007;128(7):275].

One of the steps that was skipped to save time was trans-

lation into Spanish of the trial protocol. Only the summa-

ry, the application to the national regulatory agency, and

the patient consent form were translated into Spanish.

Because medical writers in Europe are also frequently

translators, readers of TWS may have experience with

similar situations. Is the entire protocol usually translated

in your setting? If not, why not? Have unsatisfactory

translations in the past led to the conclusion that transla-

tion is not worth the cost? Do all clinical researchers read

English well enough to follow the protocol correctly? Has

requiring clinical researchers to use documents in English

ever compromised the quality of the data they collected?

Panace@ (www.medtrad.org/panacea), an on-line, mul-

tilingual, open access journal read mostly by medical,

pharmaceutical and life science translators and editors,

publishes articles in Spanish, English, and other main

European languages. The journal enjoys high access and

download rates, and the guest editors hope this special

issue will reflect views from many countries because

policies and practices may differ.

If you’d like to submit an article for the upcoming spe-

cial issue of Panace@ on clinical trials, please contact

me at [email protected]. The deadline for man-

uscript submittal is 1 April 2008.

Elsevier withdrawsJune started well with the announcement on 1 June that

Elsevier is to withdraw from its exhibitions for the

weapons industry. The company’s chief executive offi-

cer said, “It has become increasingly clear that growing

numbers of important customers and authors have very

real concerns about our involvement in the defence exhi-

bitions business”.

http://www.reed-elsevier.com/index.cfm?articleid=2084:

Call for Applicants for EMWAProfessional DevelopmentCommitteeThe EMWA Professional Development Committee(EPDC) would like to invite applications from EMWAmembers for two positions on the committee.

As a committee member you will be involved in allaspects of developing and maintaining the EMWAProfessional Development Programme including thequality and type of workshops that are offered and aid-ing the development of new workshops through thementoring system. The core of EMWA is the EPDP andby serving on the EPDC you can help to shape and guidethe future of this vital programme. Remember, there ismore to EMWA membership than just leading or attend-ing workshops and networking; the chance to gain expe-rience in a planning or managerial role is also invaluable.

If you would like to contribute to the work of the EPDCby applying for this post, or are tempted but would liketo know more, please contact the Education Officer,Stephen de Looze ([email protected]) orany member of the EPDC (details on the EMWA web-site) who will be happy to provide more details.

Komma Kummer1 in Berlin

This photograph of a façade from the palace ofSanssouci in Berlin was taken by Rainer Bischoff.Sanssouci was the summer residence of King FriedrichII. Apparently he called it Sanssouci (which is Frenchfor ‘without sorrow’) as a reminder of the blissful daysof his youth before he became weighed down with theduties and responsibilities which come with being a king(or for us ordinary folk ‘growing up’). What RosieBischoff ([email protected]), who sent the photo-graph for TWS, would like to know is what possessedFriedrich to put a comma between sans and souci. Shehas sent an email to the palace management to ask themto explain the comma. To date she has not received areply leading her to the conclusion that “some peoplejust do not understand what is important in life!”

1 The German 'Komma Kummer' translates as 'Comma distress' in English.



51

“No point to PowerPoint, saysprofessor”This is the title of an article written by Richard Alleyne

[1]. He accompanies the article with a photograph of a

lady yawning to illustrate Professor John Sweller’s scien-

tific explanation for why a room full of PowerPoint view-

ers yawn within a couple of minutes of seeing the first

slide. We illustrate things slightly differently in TWS.

[Photo credit: Marlies Kari Neuner]

Sometimes I get the impression that the executives I work

with spend most of their time presenting what other exec-

utives in the company are doing to yet other executives in

the company. That is on the assumption that there is

somebody (apart from me) doing some work rather than

presenting about work. All these presentations are given

with the aid of PowerPoint. But wait, what did John

Sweller say?

“The use of the PowerPoint presentation has been a disas-

ter. It should be ditched.”

John Sweller, April 2007

This could leave a lot of my executives without a job and

the statement predictably caused a ripple through Web

forums [2]. So we need to look at it a bit seriously.

John Sweller is a professor at the School of Education,

University of New South Wales in Sydney. He foundedthe Cognitive Load Theory in the 1980s. The theoryrelates to ‘working memory’. The part of the brainresponsible for this memory provides temporary storageand manipulates information necessary for complex cog-nitive tasks, such as language comprehension, learningand reasoning [3]. According to Sweller everything we areaware of goes through working memory, which has a lim-ited capacity of only three to four items of information thatcan be held for only three to four seconds. Almost all infor-mation goes after 20 seconds, unless there is rehearsal.

Working memory is impaired by bombardment by redun-dant information. This is where the PowerPoint thingcomes in. If one form of instruction is intelligible andadequate, providing the same material in another form hasa redundancy effect which impairs understanding.Therefore rather than presenting words as text on a screenand reading from the screen the words should just be said.Alternative we could all get on with doing some work andjust send our words as a PowerPoint presentation to col-leagues without wasting time giving the presentation.

If you do feel compelled to give a presentation then youshould think about what you put on the slide. Sweller con-cluded that using different modalities—audio and visu-al—increases the capacity of working memory and under-standing. He says it is effective to speak to a diagrambecause this combines the audio modality of hearing thewords with presenting the information in a different formby the visual modality. Surely then PowerPoint should notbe ditched but used effectively to present illustrationsrather than repeat your spoken text.


1. http://www.telegraph.co.uk/news/main.jhtml?xml=/news/2007/04/19/nppoint19.xml

2. http://www.presentationzen.com/presentationzen/2007/04/is_it_finally_t.html

3. http://www.unsw.edu.au/news/pad/articles/2007/mar/Cognitive_load_theory.html

500 words are not enoughBeate Wieseler [see box entitled ‘Meeting the final goalof trial registration’ TWS 15(1), 2006 page 61] is disap-pointed by the ICMJE’s statement1 that abstracts of morethan 500 words can be considered a prior publication ofresults by journals and preclude publication of a full arti-cle in the journal. While the ICMJE confirms that resultspresented as an abstract of less than 500 words will not beconsidered to be a previous publication, the editors clear-ly state that “Researchers should be aware that editorsmay consider more detailed deposition of trial results inpublicly available registries to be prior publication.” Anabstract of 500 words cannot include sufficient informa-

tion for use of a study in a systematic review and cannotsufficiently explain the methods and results of a study.The rosiglitazone results reports in the GSK registry,which are based on a study synopsis according to ICH E3,generally were longer than 500 words and hardly hadenough information. There is clearly a need for furtherdebate to reach the final goal of trial registration.

1 Laine C, Horton R, De Angelis CD, Drazen JM, Frizelle FA, Godlee F, Haug C,

Hebert PC, Kotzin S, Marusic A, Sahni P, Schroeder TV, Sox HC, Van Der

Weyden MB, Verheugt FWA. Clinical trial registration. Looking back and mov-

ing ahead (editorial). JAMA 2007; June 4: E1-E2.



Message from thePresident By Julia Forjanic Klapproth

Wow, what a conference. This year’s conference in Vienna

was the second in a row to have a theme. As Vice President

I developed the theme idea to expand upon what EMWA

offers at its conferences in order to reach out to a broader

scope of writers—both advanced writers and writers in

non-regulatory areas. And the popularity of this confer-

ence, in my opinion, is the clearest indication that the

theme idea is working. Most of the workshops and events

at this conference sold out within the first 3 weeks, some

within 5 days. We have never had such a rush on registra-

tions as we had this year, which shows that we are offering

things that interest a lot of people. Not only that, the rapid-

ness with which people sent

in their registrations this year

is now comparable to the

way the events at the AMWA

annual conference sell out—

an organisation of much larg-

er dimension. We are moving

onto a new stage of size and

calibre. This is exciting for me, personally, because I see

that the idea of the themed conference is achieving what I

had hoped for. EMWA is attracting a larger audience and

becoming a forum for wider discourse.

But I am aware that growth like this can also be over-

whelming at times. I have a 3 ½-year-old son and it is so

rewarding to watch him grow and develop. He is at that age

when he is adamant about wanting to show me how big he

is and how he can do everything on his own. And to a large

extent I give him as much independence as I can. But there

are moments, for example when I turn around and see him

standing precariously on top of a high fence over a chunk

of asphalt yelling “Mommy, Mommy, look at me”, when I

realise that it is important to take control of the situation.

Leading a rapidly growing organisation like EMWA is a

similar experience. It thrills me to see how successfully it

is growing. But I realise that to meet the expectations of its

rapidly growing membership, processes and systems need

to be brought into place to keep up with the pace.

During our annual general meeting (AGM) this year the

members made it clear that we need to work on the logis-

tics of coordinating EMWA behind the scenes. With our

improved economic situation we are now able to invest in

electronic systems that will allow us to manage our data-

bases and conference registration online. We intend to have

such a system in place for the Basel conference this

Autumn. However, while such an electronic system will

help us sort out many of the problems discussed during the

AGM, electronics alone will not solve everything. We will

need to look at all aspects of how EMWA is run and come

up with a system that includes clear processes for commu-

nicating to members and workshop leaders to avoid misun-

derstandings. We will need to make sure conference pro-

grammes are finalised further in advance of the conference

date to give more time for registration. The full conference

brochure will be reintroduced by popular request. And I am

sure as we assess the situation we will find other processes

that need to be optimised. Improving these things will be

crucial to maintaining the quality of what EMWA offers as

well as our credibility as a professional organisation. And

it is our foremost priority.

In the next issue of The Write Stuff I will write an article

describing the structure of the Executive Committee that

has now been elected into place. I realise that there are sev-

eral points that people are unsure about and I hope to clar-

ify these so that the membership has full transparency

around what the new structure is and how it is meant to

function.

Outside of these logistical issues, however, only positive

feedback on the conference was received. This was the first

conference I have seen in years where the advanced writ-

ers were as enthusiastic about the conference programme

as the new writers. There was once again a great social

atmosphere, which was aided by the wonderful social pro-

gramme developed by Head Office. It is this sense of com-

munity that I love about EMWA and which makes EMWA

conferences so special.

I have to say I have arrived home from this conference

tired but content. As a parting word I again want to thank

everyone, especially the workshop and seminar leaders,

plenary speakers, and discussion panel members who vol-

unteered their time and without whose enthusiasm a con-

ference like this could never be realised.

Julia Forjanic KlapprothTrilogy Writing & ConsultingFrankfurt am Main, [email protected]

EMWA’s new ECstructure will be

described in detailin September’s TWS

It is impossible these days to write anything about punctu-

ation in English without Lynne Truss’ phenomenally suc-

cessful ‘Eats, Shoots and Leaves’ hovering in the back-

ground [1]. Some would say: ‘She did it all. Why bother to

write more?’ As far as I am qualified to say this, I think she

did a very good job on the comma and other punctuation

marks, but went overboard on the apostrophe (but then we

all have our bugbears). When the book was launched, she

did give EMWA much free publicity, because in a newspa-

per article (I have been unable to locate which, although I

saw it at the time) she publicly criticized an entry in our

conference programme. The entry was ‘New Members

Welcome Drink’, and she felt that there should be an apos-

trophe after the ‘s’. This is also immortalized in her book (p.

51), although the source is not quoted there—and the point

will remain controversial. I had reviewed the programme in

question and taken out the apostrophe, as I felt that the new

members would not be bringing their own drinks.

We did not come in for any criticism with regard to our useof commas, however. This is surprising because the commais as controversial as the apostrophe, and variants on thequestion ‘Should I put a comma here?’ are amongst themost frequent I hear.

Lynne Truss closely observed and analysed the popular useof punctuation (where transgressions prevail: tea’s +cakes’, ladie’s toilet, do-nut) and did not cast her eye specif-ically over usage in scientific texts. There is much overlap,of course. I shall try to pick out here some situations whereparticular attention should be paid to comma usage in ourcontext. Otherwise, the following websites (and there aremany more) make illuminating reading and describe thebasic rules and conventions much better that I can:

http://owl.english.purdue.edu/handouts/grammar/g_comma.html

http://www.grammarbook.com/punctuation/commas.asp

http://www.stpt.usf.edu/pms/comma.html

If English is your first language, you have probably beensurprised that some writer colleagues with English as a sec-ond language have an inordinate interest in the comma.Apart from a general interest in ‘getting it right’, they areprobably used to incontrovertible rules in their first lan-guage that determine when a comma is needed or not. Thegrey area in English is—unfortunately—enormous. This iswhy even those whose first language is English also strug-gle with the comma—as I do.

Apart from the few rules we have, an effective way ofdeciding where to put a comma in English is to read your

sentence out loud, or ask someone else to read it out.

Without realizing it, writers often use commas for one of

two purposes: to set off an element of a sentence from an

introductory clause or introduce a new idea with a slight

pause (Although 225 samples were taken, only 22 had been

properly fixed, and 2 of these were contaminated), or to

separate two or more elements when you would pause

when speaking, or the voice would rise. This is only an

effective way of deciding if you are very familiar with

usual English intonation (and this varies from region to

region and country to country anyway). Another common

situation is when deviating from normal or expected word

order (subject-verb-object interposed with adverbials usu-

ally after the verb) to obtain stress.

This means that we have to have some ‘rules’ or ‘conven-

tions’, even if—like so much in the English language—

they will never be reliable. One of the main things is to

avoid overuse, even if it is not strictly incorrect, because I

think that overuse of the comma is more disconcerting to

the reader than underuse. My main advice with the comma

is ‘If in doubt, leave it out’, but there are definitely many

instances where it is indispensable.

First, a few basics (not exhaustive):

What do commas actually do?Like all other punctuation marks, they send out messages

to the reader, facilitate comprehension, awaken expecta-

tions, and contribute to meaning and sense. Some punctu-

ation marks in English send out very strong messages, such

as the em-dash (—) or the colon (:), and others a weak mes-

sage, such as the semi-colon (;) or square brackets ([ ]).

The problem with the comma is that it sends out mixed

messages and can be used either singly or in pairs, and,

specifically in our area in medical and scientific writing in

Europe, speakers of English as a second language may be

used to the comma in their first language giving the reader

a very much stronger message than in English. When used

in pairs, they separate off information in some way, but so

do brackets (parentheses) and em-dashes. These three

devices often appear interchangeable, and there is a hierarchy:

brackets are weakest and em-dashes strongest, with com-

mas in the middle. Some examples are given below.

Whatever: the comma should be used only when it helps

the reader to understand your sentence, and not only

because you are observing a ‘rule’ or a sometimes spurious

convention (e.g. you must have a comma before ‘too’ at the

end of a sentence or after ‘i.e.’ [see below]).

If in doubt, leave them out—or maybe not?Subtitle: Do the best you can!by Alistair Reeves



53



> > >

Some instances where commas aredefinitely wrongDecimal separators. Very basic and should be easy, but

even these days I still see this error almost weekly: the

comma is not a decimal separator in English: 8,9 mg/dL is

incorrect; 8.9 mg/dL is correct1. 10.000 for ten thousand is

not correct, it should be 10,000. The raised comma

(10’000) may appear on some calculator displays or be

used in the IT world, but it has not caught on yet, and peo-

ple seem to be strangely resistant to this sort of change.

Even though 10<space>000 is recommended from some

quarters, the space is too soft a character to catch on quick-

ly, so we are stuck with the comma. As boring as it is, you

just have to change all those commas to decimal points (or

vice versa) in your texts and tables.

Used before ‘that’ and ‘if’ (when ‘if’ is erroneously used

to mean ‘whether’). A comma is not used before ‘that’

when ‘that’ is used after an introductory clause (The EMEAclaimed that … or She said that …) or as part of a defining

clause (The samples that we received today were allspoiled) (see below). If you feel you have to write: Theinvestigator enquired if we could send her… , do not be

tempted to put a comma before the ‘if’. In any case, it

should be ‘whether’ and not ‘if’ when you are writing, and

there is no comma before ‘whether’ either.

After ‘both’, when it is used as an adverb. ‘Both’ is both

an adjective and an adverb. A comma would be incorrect

after ‘both’ in the following sentences: Similar findingswere made in both the elderly and young subjects; Both thecats and the rats showed considerable weight loss. Both

when used as an adjective (in both groups) is also obvious-

ly not followed by a comma.

Between non-coordinate adjectives. Non-coordinate

adjectives are adjectives that cannot be exchanged in posi-

tion or cannot be separated by ‘and’ (the above websites

give good help on this one). The adjectives in the follow-

ing sentence are non-coordinate: Insert the long white plas-tic tube into the base of the device. You cannot reasonably

say: Insert the long and white and plastic tube…, nor can

you say ‘the plastic white long tube’, and commas are

therefore not needed. The adjectives in the following sen-

tence are coordinate: Expensive, labour-intensive studiesare a thing of the past. This is because you could also say:

Labour-intensive, expensive studies are a thing of the past.And you could replace the comma by an ‘and’. The prob-

lem is that many instances of this involve mixtures of non-

coordinate and coordinate adjectives, use is not consistent,

and sometimes it is just a matter of feeling.

Before ‘because’. A sweeping statement: there is never a

comma before ‘because’ (1), unless it is used after the sec-

ond of a pair of commas (2). Examples: (1) The subject was

withdrawn because she developed pneumonia; (2) Dairyproducts must be avoided, even if the patient has toleratedthem well before, because they can inactivate the activesubstance … . If, however, the second sentence read Dairyproducts must be avoided, even if the patient has toleratedthem well before because they were taken in moderation,

there is no comma before ‘because’ because the ‘because’

clause is explaining why they were well tolerated and not

why they must be avoided.

Some instances where commas aredefinitely rightWhen they are necessary to avoid confusion. This cov-

ers a multitude of issues. Sometimes it just makes things

easier to read and understand, so the reader does not have

to backtrack. Making a reader backtrack is never desirable.

Examples: If the adverse event is serious details of con-comitant medications taken over the past two weeks mustbe documented; or Despite this new information on genet-ic alterations changed our opinion. In the first example,

the mind automatically reads ‘serious’ as a modifier of

details, and it is actually the complement of the verb ‘to be’

in this clause, so ‘serious’ should be followed by a comma.

In the second example, it is not until you reach ‘changed

our’ that you realise that something is wrong here and that

there should be a comma after ‘this’. In both cases you

have to backtrack because of the omission of a comma.

When the clauses in a sentence have different subjects.

This is explained in more detail below and does not apply

to ‘if clauses’ at the beginning of a sentence: If the samplesare out of date, they must not be distributed. Here a comma

is needed, but The samples must not be distributed if theyare out of date does not need a comma.

When they are used in pairs around commenting clauses.

The ‘which’ clause in the following sentence is called a

commenting clause: The blood samples, which will beanalysed on 24 June 1996, must not be deep frozen forlonger than 1 week. This actually means that all blood sam-

ples concerned will be analysed on 24 June and that none

of them must be deep frozen for longer than 1 week. What

happens when we delete both commas? The blood sampleswhich will be analysed on 24 June 1996 must not be deepfrozen for longer than 1 week. The sentence now means

that only the blood samples scheduled for analysis on 24

June 1996 must not be deep frozen for longer than 1 week.

The ‘which’ clause here is called a defining clause.

Speakers of British English have been tending for years

now towards ‘that’ instead of ‘which’ in defining clauses:

The blood samples that will be analysed on 24 June 1996must not be deep frozen for longer than 1 week. This is OK.

What is impossible is: The blood samples, that will be

1 If you use the English version of Word and have not changed any of the language settings and have the grammar check switched on, you will note that if you write ‘8,9 mg/dL’

the comma and the ‘9’ are underlined with a zigzag line, indicating that this has been recognized as an error, because the system expects a space after a comma. I generally like

to think that I am better at grammar than Word, but in this case it is a good indicator that something needs correcting!

If in doubt, leave them out—or maybe not?



55

> > >

analysed on 24 June 1996, must not be deep frozen forlonger than 1 week. Commenting clauses always have to

be constructed with ‘which’ and always need commas, and

if you leave out the commenting clause, you must be left

with a complete sentence.

In verbatim quotes. Whether you write “That’s when Itripped and cut my head”, the patient said or The nursesaid, “I gave her the injection at 10 o’clock”, you need a

comma. In the first example, I have used typical European

positioning of the comma after the inverted commas; typi-

cal US positioning would be the reverse (,”). This does not

apply to the comma after ‘said’ in the second example.

Before ‘or’ when there are more than 2 choices. No

comma is need in: Patients usually respond to amoxicillinor cefixime. A comma is needed in: Patients usuallyrespond to amoxicillin, cefixime, or ofloxacin (at least

that’s my opinion). This is like the use of the serial comma

before ‘and’ [2].

What about the grey area?I have dealt with two regions in this grey area in previous

TWS articles on myths about English: the supposed oblig-

atory use of a comma after ‘e.g.’ and ‘i.e.’ (I am against it)

[3], and the use of the comma before ‘and’ in lists (I am for

it) [2]. There are many others, e.g.: should there be a

comma before ‘respectively’ after subsequent running lists

to establish relationships in a sentence, or should there be

a comma before ‘too’ when used to mean ‘also’ at the end

of a sentence. Brief answers to these: unfortunately, respec-

tively is often grossly overused—and inappropriately—by

many writers who confidently hope that the addition of this

encumbrance will disentangle their sentence for the reader;

whatever, it never needs to be preceded by a comma, as far

as I am concerned. ‘Too’ at the end of sentences should

occur only very rarely in scientific texts, as it is very much

a spoken, literary or journalistic device; if you do use it,

you don’t need a comma before it. The comma does not

improve comprehension whether it precedes ‘respectively’

or ‘too’. ‘Too’ in the middle of a sentence should be sur-

rounded by commas, but it is really only suited to informal

or journalistic use: NHS trusts, too, have been feeling thepinch since the new regulations were introduced.

To illustrate various other points with commas, I chose a

short paper from the BMJ about forest plots [4]—not

because I felt that the comma was used particularly well or

particularly badly in the paper. I have recently been dealing

with forest plots and liked the way it briefly summarised

their evolution. Steff Lewis, one of the authors, permitted

me to tear her sentences apart.

The following two sentences appear in the summary of the

article: Forest plots, in various forms, have been publishedfor about 20 years. During this time, they have beenimproved, but it is still not easy to draw them in most stan-dard computer packages.

Why did the author put commas around the preposi-

tional phrase ‘in various forms’? Because it draws the

reader’s attention to the phrase by introducing two pauses.

To achieve this, the author deviated from the expected

word order in English. The message is similar if you write:

1) Forest plots have been published in various forms forabout 20 years, or 2) Forest plots have been published forabout 20 years in various forms. The phrase ‘in various

forms’ before the verb in the original sentence modifies the

subject (forest plots) and immediately makes the reader

aware that forest plots can take different forms. This infor-

mation is, of course, also provided in sentences 1) and 2),

but it is not stressed in 1) because it uses the expected word

order in English when no emphasis is intended on any ele-

ment (subject-verb-object-time interposed with adver-

bials). Sentence 2) adds some stress to ‘in various forms’

because the time is not at the end, but it is not as strong as

before the verb with commas. Note that the omission of ‘in

various forms’ in the author’s original sentence still leaves

a complete sentence: this is a must when using pairs of

commas to surround any phrase or clause in this way.

Are commas actually necessary around ‘in various

forms’? The addition of commas adds extra emphasis, but

they are not necessary. But this is definitely an instance

where I would support the use of commas. Ultimate stress

would be achieved by writing Forest plots—in variousforms—have been published for about 20 years, but the use

of the em-dash seems exaggerated here.

Do I need a comma after ‘During this time’? This is a

matter of personal preference. If I start a sentence with a

time clause or phrase (precise or imprecise, e.g.: On 26June 1963, or At Visit 6, or Recently), I am deviating from

the expected word order in the English sentence (time at

the end), and I like to add a comma. Many people don’t.

Hence, During this time they have been improved would

also be fine.

Do I need a comma before ‘but’? Yes. If you introduce a

new idea into a sentence with a conjunction, you need a

comma before the conjunction. This is not always observed

when people use ‘and’, especially in short sentences. If I

have a long sentence (for these purposes a long sentence is

about 1.5 lines of 12-point text on an A4 page with 2.5 cm

margins), with two or perhaps three clauses, I will almost

always separate these with commas before the ‘ands’ or

other conjunctions, and definitely do so if the subject

changes. My sentence above: I have recently been dealingwith forest plots and liked the way… has the same subject

in each clause, so a comma is not needed. A comma is

needed in the following sentence: The patient was founddead in the bathroom, and her husband reported that shehad been complaining of breathlessness for about 2 hours.And in this one: The patient then developed acute renalfailure and became unconscious, and later a creatinineclearance of … was determined.





An extract from the introduction of the forest plot article:

In a typical forest plot, the results of component studies areshown as squares centred on the point estimate of theresults of each study. A horizontal line runs through eachsquare to show its confidence interval—usually, but notalways, a 95% confidence interval.

Do I need a comma after ‘plot’? Again, you don’t actual-

ly need a comma here, but because the author wanted to

stress the idea of ‘the typical forest plot’, it is appropriate

to pull the idea forward in the sentence and add a comma,

as this underlines the deviation from the expected word

order. Consider this rearrangement: The results of compo-nent studies in a typical forest plot are shown as squarescentred …. The idea of ‘typical’ gets a little lost in the mid-

dle of the sentence.

What about the punctuation in the second sentence—is

it OK? For me, no. The em-dash before ‘usually’ is too

strong, and the commas around ‘but not always’ are too

weak. The important information here is that the horizon-

tal line does not always represent a 95% confidence inter-

val. I would have edited this sentence as follows: A hori-zontal line runs through each square to show its confidenceinterval, usually—but not always—a 95% confidence inter-val. By transposing the punctuation here, the stress is clear-

ly on ‘but not always’ because it is surrounded by em-dash-

es, and the comma before ‘usually’ is necessary to tell the

reader that a new idea is coming.

When describing the history of forest plots, the author says:

However, smaller studies, with less precise estimates ofeffect had larger confidence intervals and, perversely, werethe most noticeable on the plots. (New §) Means of focusingattention on the larger, more precise, studies were sought.

Do I need a comma after ‘however’? Yes, always, at the

beginning of a sentence (and yes, you can use ‘however’ at

the beginning of a sentence). You do not need a comma if

it is used to mean by whatever method’: However you man-aged to make that mistake, I’ll never understand! You need

a comma before ‘however’ if it is used at the end of a sen-

tence (much rarer when writing, but often spoken). And what

about ‘therefore’ at the beginning of a sentence? I try to avoid

using ‘therefore’ at the beginning of a sentence, but I do think

that it should be followed by a comma in this position.

Is ‘however’ always surrounded by commas when not

used at the beginning or end of a sentence? Yes. What

about ‘therefore’? No—either with or without commas as

far as I am concerned.

Is the comma after ‘smaller studies’ appropriate? I

don’t think a comma is needed here.

There is no comma before ‘and, perversely’. Right. Both

clauses have the same subject and so this is not necessary.

Had the sentence read However, smaller studies with lessprecise estimates of effect had larger confidence intervals,and forest plots were therefore heavily criticized because

such studies were the most noticeable, a comma before the

‘and’ would be needed. A change of subject in a sentence

means that a comma is appropriate before the ‘and’ (or

whatever other conjunction—‘and’ is just about the most

common) introducing a new clause. This is illustrated by

the following sentence from later in the paper: The plot wasnot called a ‘forest plot’ in print for some time, and the ori-gins of this title are obscured by history and myth.

What about the commas around ‘perversely’? These are

appropriate, and I might even have been tempted to replace

them with em-dashes: ‘perversely’ is a strong word and car-

ries the message in this sentence. The commas are weak here.

Is the comma between ‘larger’ and ‘more precise’

appropriate? Yes. But only if the author meant that the

studies that were more precise, were also larger. This would

mean that these modifiers (adjectives) of the word ‘studies’

are coordinate, or interchangeable, and the comma could be

replaced by ‘and’. If this is what she wanted to say, she

could also have said: Means of focusing attention on themore precise, larger studies were sought. Without a comma,

it would mean that there may have been many more precise

studies, but not all of them were larger, as she wished to

focus only on the larger ones. But this was not the case.

And what about the comma after ‘precise’? The comma

after ‘precise’ is incorrect. The inappropriateness of the

comma becomes obvious if we add the ‘and’ between the

coordinate adjectives: Means of focusing attention on thelarger and more precise, studies were sought. It is immedi-

ately obvious that it is wrong—we have two modifiers with

nothing to modify because the phrase is curtailed by the

comma, and ‘studies’ immediately looks like a new subject

in the sentence. The author’s use of the comma here was

influenced by the comma between the coordinate adjec-

tives (and—by the way—this error was also missed by the

BMJ editors!).

After all of this, you will probably be tempted to ‘leave the

comma in’—just in case. There are plenty of clever exam-

ples where a comma or a couple of commas change mean-

ing entirely, even in a very short sentence, and apparently

millions have been lost and won because of the presence or

absence of a comma. Some authors still ask me: ‘Does it

really matter?’ Sometimes it doesn’t, and it’s very unlikely

that your marketing authorization application will be

turned down because of inappropriate commas, but this

doesn’t mean that we shouldn’t try to do the best for our

readers and keep ourselves happy at the same time by

doing the best we can.

Alistair ReevesAscribe Medical Writing and TranslationWiesbaden, [email protected]

References:

1. Truss L. Eats, Shoots and Leaves. Profile Books Ltd. London, 2003.2. Reeves A. More Myths about English (3). TWS 2006;15(4):139.3. Reeves A. Myths about English. TWS 2006;15(1):22.4. Lewis S. Forest plots: trying to see the wood and the trees. BMJ 2001;322:1479-80.

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Commas



by Valerie A. Elliston

Commas are often scattered like confetti: in a kind of

cheerful abandon but without any particular purpose

beyond a feeling that they will somehow enhance the writ-

ing purely by their presence. However, they have several

clear functions and, in some instances, can change the

meaning of a sentence.

We can assume that the main purpose of grammar and

punctuation is to make a piece of writing clear and unam-

biguous so that the reader understands the writer’s inten-

tion at once, and does not have to re-read phrases or sen-

tences in order to grasp their meaning. To help in achieving

such clarity, the comma has four distinct uses: listing, join-

ing, indicating gaps, and bracketing or isolating. (Note the

Oxford comma after the word ‘gaps’; this use has been cov-

ered by Richard Clark’s article ‘The fatal comma’ on page

? of this issue) Each group will be considered in turn, with

badly punctuated sentences indicated by an asterisk (*).

The listing comma is used when three or more words,

phrases or sentences could be linked by the words and or

or. This substitution avoids clumsiness and helps the

smooth flow of the language.

Spanish is spoken in Spain and in Central America and inmost of South America and in many other parts of the world.

This sentence is correct, but sounds rather clumsy and

repetitive.

Spanish is spoken in Spain, in Central America, in most ofSouth America and in many other parts of the world.

The comma improves the flow here and in the following

example.

We can fly to Mumbai via Moscow or via Athens or via Cairo.

We can fly to Mumbai via Moscow, via Athens or via Cairo.

They spent the mornings shopping in Bond Street andenjoying coffee in Fortnum’s and wandering around theWallace Collection and trying to hail taxis.

This could be improved by the use of commas. Note that

each activity is mentioned in a phrase, not a complete sen-

tence. The listing comma is therefore correct.

They spent the mornings shopping in Bond Street, enjoyingcoffee in Fortnum’s, wandering around the WallaceCollection and trying to hail taxis.

Note: two complete sentences must not be joined with a

comma, but three or more complete sentences can be

linked with listing commas plus and or or.

*Julia speaks Spanish, Rose speaks German.

Julia speaks Spanish, Rose speaks German and Johnspeaks French.

Note: in British usage it is not usual to put a listing comma

before the word and or or (the Oxford comma again) but it

is usual in American English. However, the comma should

be added if it makes the meaning clearer, as in

This applies to the London boroughs of Barnes, Wandsworth,and Kensington and Chelsea.

Here, the comma before the first and shows that

Kensington and Chelsea form one borough, not two.

However, this use of the listing comma can convey a mean-

ing that is the opposite of what is intended, as in

*Treatment consisted of exercises, appropriate drugs,

avoiding fatty foods, and alcohol.

In this instance, the final comma implies that alcohol is

part of the treatment! Omit the comma and the meaning

becomes clear.

A listing comma is also used in a list of modifiers which all

modify the same object. In each case, the comma could be

replaced by the word and.

Her short, fair, curly hair expressed her lively personality.

Her short and fair and curly hair expressed her lively per-sonality.

Replacing the commas by and does not alter the sense.

I discovered an ancient gold coin in the field.

In this case, we cannot insert and between ancient and goldbecause the word ancient modifies the gold coin, not sim-

ply coin. It would sound odd to say

*I discovered an ancient and gold coin in the field.

To sum up the use of the listing comma:

Use one in a list wherever the word and (or or) could be used.

Put one before the word and or or if this is essential to

make the meaning clear. > > >



59

Commas> > >

The joining comma can be used to join two complete sen-

tences into one, but it must be followed by an appropriate

connecting word such as and, or, but, while, yet (and forwhen this means because).

Note the construction of the above sentence: there are, in

fact, two complete sentences joined by a comma plus the

word but. The same two sentences could be written like

this:

The joining comma can be used to join two complete sen-tences into one. However, it must be followed by an appro-priate connecting word such as ...

Or like this:

The joining comma can be used to join two complete sen-tences into one; however, it must be followed by an appro-priate connecting word such as ...

Note that, in these alternative examples, the connecting

word is however, because the punctuation marks being

used are the full stop (full point) or the semicolon.

The use of the joining comma relates to two different types

of clauses: subordinate and coordinate. Here are some

examples of the former:

She was late because the bus had already left.

He’ll bring the car if it rains.

The main clauses here are She was late and He’ll bring the car.

The subordinate, or less important, clauses are becausethe bus had already left and if it rains. The comma is not

needed between the two clauses here because the main

clause is written first and the complete sentence runs

smoothly to the end. However, if the subordinate clause

comes first, the comma is needed. So far, we have been

considering the smooth flow of the sentence, but there are

instances where this joining comma can affect the meaning

and force the reader to stop and re-read for sense. For

example,

Heavy damages had to be paid to a man who fell off hisgarage roof and sustained head injuries because a doctorin A & E had failed to diagnose skull fracture.

This man did not fall because of the doctor’s failure. First,

he fell, then he was taken to hospital, then the doctor failed

to diagnose skull fracture. Finally, damages had to be paid

because of that failure. A comma before the word becausewould help to clarify this. It would be even clearer if the

subordinate clause came first:

Because a doctor in A & E had failed to diagnose skullfracture in a man who fell off his garage roof, heavy dam-ages had to be paid.

(Of course, it would be clearer still to write a man who hadfallen etc. using the past perfect tense to show the correct

sequence of events.)

A coordinate clause is of equal, not subordinate, impor-

tance to the main clause, as in the following example:

The risks of staging a musical are considerable, and thebackers are afraid of sustaining huge losses.

Here are two equally important clauses, main and coordi-

nate. They are linked by the joining comma and the word

and. Compare with

The risks of staging a musical are considerable becausethere are so many factors to take into consideration. Here,

we have a main clause followed by a subordinate clause

introduced by the word because. No comma is needed.

However, if the subordinate clause comes first, the comma

is needed.

Because there are so many factors to take into considera-tion, the risks of staging a musical are considerable.

Say these sentences aloud to hear the difference. Here are

some more examples of the joining comma with coordi-

nating conjunctions:

Millions of pounds have been poured into this project, yetwe still have nothing to show for it.

You must meet the deadline for your essays, or they will notbe considered for marking.

Be careful of using nor as a coordinating conjunction.

The doctor could not use thiopental in this case, nor couldhe use methothohexital. Note here that the use of the nega-

tive conjunction nor forces a change in the word order in

the coordinate clause. It would be clearer to write:

The doctor could not use thiopental or methohexital in thiscase. Or

The doctor could use neither thiopental nor methohexitalin this case.

Here, we do not have a main clause plus a coordinating

clause. A clause (as opposed to a phrase) requires a verb.

Hence, the joining comma is not required.

The English are bad at learning other languages, while theDutch are particularly adept at it.

Note: while, not whilst. Whilst means although, as in

Whilst I disagree with you, I must defend your right tospeak out.

Joining two complete sentences with a comma but without

a coordinating conjunction is one of the commonest of all

errors in punctuation. The rule to remember is:

Use a comma to join two complete sentences only when

also using one of the words and, or, but, yet, while. Do

not use a joining comma in any other way.

The gapping comma simply shows that one or more words

have been omitted to avoid repetition. However, if a sen-

tence is clear without a gapping comma, do not use it. If

you have a doubt, put it in.

Some of the patients showed signs of distress; othersshowed signs of nausea.



Commas

Some of the patients showed signs of distress; others, ofnausea.

The comma after others indicates that the words showedsigns have been omitted but can be taken for granted. Note

the semicolon between the two parts of the sentence. This

is because, when the omitted words are included, the sec-

ond part forms a complete sentence; therefore, a comma

cannot be used here.

The isolating or bracketing commas are the most often

used. A pair of commas encloses an interruption that does

not interfere with the smooth flow of the point being

expressed. One should be able to remove all the words

between the two bracketing commas without changing the

sense of the sentence.

These findings, we suggest, make us doubt his hypothesis.

These findings make us doubt his hypothesis.

He was, needless to say, absolutely exhausted.

He was absolutely exhausted.

The children were, in spite of everything, still full of energy.

The children were still full of energy.

Gordon Brown, it would seem, will become Prime Minister.

Gordon Brown will become Prime Minister.

We have been obliged to conclude, after careful study of allthe evidence, that the result, despite all their efforts, isunsatisfactory.

We have been obliged to conclude that the result is unsatisfactory.

Note that there are two interruptions in the last sentence,

each enclosed within a pair of commas. In each of the

examples, the words within the pairs of commas can be

removed without changing the sense of the whole. This is

a useful way of checking. If the whole sentence fails to

make sense, something is wrong. Note the following:

*Yet, over the horizon, lay the enemy ships.

If the words between commas are removed, the sentence

fails to make sense:Yet lay the enemy ships.

It should read:

Yet over the horizon lay the enemy ships.

The phrase over the horizon is not an interruption but an

essential part of the whole sentence.

Bracketing or isolating commas are also relevant when

considering defining and non-defining relative clauses. I

have covered this topic in a previous issue of TWS [see 15

(1):31].

Here are some interruptions that occur at the beginning or

at the end of a sentence when only one isolating comma is

required:

Having lived most of her life in France, Julia is fluent inFrench.

The pronunciation of English is changing by the day, or sowe are told.

The words isolated by the single comma could be removed

without changing the sense of the whole. When checking,

make sure that the words isolated by commas are true inter-

ruptions and not an essential part of the meaning.

*Just before leaving the bus caught fire.

The reader registers just before leaving the bus and has to

re-read to catch the real meaning:

Just before leaving, the bus caught fire.

To sum up the use of bracketing or isolating commas:

Use a pair of commas to enclose a mere interruption

which could be omitted from the sentence without

changing its meaning.

Make sure the words enclosed by the commas form a

true interruption.

If the interruption occurs at the beginning or end of a

sentence, use only one comma.

To sum up the use of commas in general:

Use a listing comma in a list when and or or could be

used instead.

Use a joining comma before and, or, but, yet or while.

Use a gapping comma to show that words have been

omitted.

Use a pair of bracketing or isolating commas to separate

an interruption.

Valerie A. EllistonColchester, UK

Valerie A. Elliston is a freelance writer and registered

indexer. She was formerly an adult education lecturer

in English language and literature.

The importance ofproofreadingNotice in a British Sarova Hotel:

‘When you stay with Sarova Hotels, whatever your expe-

rience, please take a moment to fill in one of our comment

cards and leave with our receptionist. On your departure.’

I chose not to leave with the receptionist, but if anyone

would like to give this a try, I’d be happy to tell you

which hotel it was.


Saved from deathI am not sure if this story is true or not, but it illustrates the

power of commas. Czarina Maria Fyodorovna once saved

the life of a man by transposing a single comma in a war-

rant signed by her husband, Alexander III, which exiled a

criminal to imprisonment and death in Siberia. On the bot-

tom of the warrant the czar had written:

“Pardon impossible, to be sent to Siberia.”

Maria Fyodorovna changed the punctuation so that her

husband’s instructions read:

“Pardon, impossible to be sent to Siberia.” The criminal

was set free.

Hanged on a commaSir Roger Casement was said to have been ‘hanged on a

comma.’ In 1914 he sailed to Germany and enlisted

German support to help Ireland gain its independence from

Great Britain. This included his unsuccessful attempts to

recruit Irish prisoners to form an ‘Irish brigade’ to fight

against Britain and drafting an unofficial treaty with

Germany to support an independent Ireland. On his return

to Ireland in 1916 he was arrested and charged under the

Treason Act of 1351. His barrister argued that because the

mediaeval act did not contain any punctuation and was

written in Norman French, that it seemed to apply only to

activities carried out within the realm (i.e. on British soil).

In translation the act read:

“If a man be adherent to the King’s enemies in his realm

giving them aid and comfort in the realm or elsewhere…”

Casement’s allegedly treasonable activities were all carried

out in Germany, so this argument could have saved him.

Nevertheless it is fair to say that this defence was very

weak! In any case, the judges claimed to find a faint virgule(a sort of prototype comma, signifying a short pause) after

the second ‘realm’ in the original act, and so he was con-

demned to death by hanging. If you want to be pedantic

you could say he was ‘hanged on a virgule’, but 99% of

people wouldn’t know what was meant—so hanged on a

comma it remains.

A costly commaThe placement of a comma in a contract between Rogers

Communications Inc. and Aliant Inc. looks like it will cost

Rogers dearly—an extra $2.13 million. Rogers thought it

had a 5-year deal with Aliant to string Rogers’ cable lines

across thousands of utility poles in Canada for an annual

fee of $9.60 per pole. But early last year Rogers was

informed that the contract was being cancelled and the

rates were going up. Impossible, Rogers thought, its con-

tract was iron-clad until the spring of 2007, and could

potentially be renewed for another 5 years. The construc-

tion of one sentence in the contract allowed the entire deal

to be scrapped with only a year’s notice, Aliant argued [1].

The contract states that the agreement “shall continue in

force for a period of 5 years from the date it is made, and

thereafter for successive 5 year terms, unless and until ter-

minated by 1 year prior notice in writing by either party.”

Rogers’ intent in 2002 was to lock into a long-term deal of

at least 5 years, but the regulators with the Canadian

Radio-television and Telecommunications Commission

(CRTC) stated that the validity of the contract came down

to the second comma in the previous sentence. Had it not

been there, the right to cancel wouldn’t have applied to the

first 5 years of the contract, and Rogers would be protect-

ed from the higher rates it now faces. The regulator stated

that the comma in question “allows for the termination of

the [contract] at any time, without cause, upon 1-year’s

written notice.” Rogers intention was to shield itself from

rate increases, but now it will see its costs increase to up to

$28.05 per pole. Rogers will probably have to pay $2.13

million more than expected, based on rough calculations.

The fatal comma



61

By Richard Clark

Quick, move it! None of us want to go to Siberia



The fatal comma

Some plain wordsWe all know how to use commas don’t we. (That was a

statement, not a question!) Just in case though, the venera-

ble Sir Ernest Gowers summarises the key issues regarding

comma usage pretty well:

“The use of commas cannot be learnt by rule. Not only

does conventional practice vary from period to period, but

good writers of the same period differ among themselves.

Moreover, stops have two kinds of duty. One is to show the

construction of sentences—the ‘grammatical’ duty. The

other is to introduce nuances into the meaning—the

‘rhetorical’ duty”[2].

I like this sort of attitude! Maybe this is because of my

deep-rooted mistrust of grammatical ‘rules’ taught as

taught at school. The grammar pedant can sometimes put

too much emphasis on the grammatical duty of commas

(see the next section) at the expense of the nuance and

phraseology of the writer, and writers often just spray com-

mas all over the place. Nevertheless, I do think that gram-

mar rules are important, though commas are a special case

for which the rules need to be bent a bit now and again.

Zero tolerance to zero toleranceAn article by John Mullan in The Guardian reports the

views of a New York-based critic, Louis Menand, on

Lynne Truss’s book Eats, Shoots & Leaves: The ZeroTolerance Approach to Punctuation [3,4], Menand was not

happy with Truss’s “strange grammar.” For example, the

dedication mentions “The striking Bolshevik printers of St

Petersburg who, in 1905, demanded to be paid the same

rate for punctuation marks as for letters.” Here, Menand

seems delighted to find “a nonrestrictive clause [that] is not

preceded by a comma. It is a wild ride downhill from

there.” (In normal English this means he wants a comma

after St Petersburg.) I think he has a point, but firstly I

would never construct this sentence in the same way such

that it needed so many commas, and secondly, the lack of

a comma doesn’t change the meaning of the sentence to

me. To Menand, presumably, it does:

“Without that comma, the dedication is to some striking print-

ers who made the demand, as opposed to some other striking

printers who didn’t. Only with a comma is the dedication to

all the striking printers (as Truss presumably intends).”

This level of sophistry is beyond me, I’m afraid. I don’t

really like the dedication—with or without an extra

comma. But, non-restrictive clauses aside (yes, I would

hyphenate non-restrictive, unlike Mr Menand), if you were

to read the dedication aloud with the intention of dedicat-

ing the book to the striking printers, then you would pause

briefly after St Petersburg. That’s as good a rule as any.

The dreaded ‘Oxford’Here we come to another example of a cross-Atlantic clash

between the British and North Americans, which also illus-

trates the importance of not following rules slavishly. At

school in the UK (in the long-gone days when someEnglish grammar was taught) we were told to put commas

between items in a list of three or more items, but that a

conjunction (such as ‘and’) took the place of a comma

between the last two items. So in the UK, most people

write ‘red, white and blue’. In the US—with the exception

of newspapers—the Oxford (or serial) comma is just about

mandatory. The argument is that as this comma is some-

times necessary to remove ambiguity, there had better be

one there always. The Oxford comma appears after the

conjunction in this list, thus: ‘red, white, and blue’.

Personally, I prefer not to use an Oxford comma, but I don’tmind using one if it removes ambiguity.

I’m not sure what the situation is like in the US, but here in

the UK many people would rather cut off their own arm

than use an Oxford comma! But if you never use an Oxford

comma you can sometimes get into trouble. For example,

consider:

“The sea, the perfume of wisteria, or a summer lunch: any

of these revived memories of an easier time.”

The removal of the Oxford comma would change the

meaning such that the perfume of a summer lunch brought

back memories of an easier time. Likewise, trouble lies in

wait for those who always use Oxford comma. Here the

‘toast, juice, ham and eggs’ rule comes into play. A comma

after ‘ham’ would make it a separate item from the eggs

(which may be the case), but if ham and eggs are served

together then the Oxford comma has to go.”

Common sense, observation and tasteI’m a simple person. I don’t know all the rules of grammar,

and all the grammatical terms used to describe them.

However, the words of Sir Ernest ring true, and provide

some comfort:

The correct use of a comma—if there is such a thing as

‘correct’ use—can only be acquired by common sense,

observation and taste.”

The use of commas is not usually a life or death matter,

though sometimes it can feel like it is. Thus, do we all need

a bit more common sense, observation and taste?

Richard ClarkFreelance Medical WriterVitruvian Medical Writing Ltd., Oxford, [email protected]

References:

1. http://www.theglobeandmail.com/servlet/story/RTGAM.20060806.wr-

rogers07/BNStory/Business

2. Gowers E. The Complete Plain Words. 3rd edition (revised by Greenbaum S

and Whitcut J). London: Penguin Books, 1986.

3. Mullan J. The war of the commas. The Guardian, 2 July 2004.

4. Truss L. Eats, Shoots & Leaves: The Zero Tolerance Approach to Punctuation.

London: Profile Books, 2003.

My writing took a small turn for the better in the 1970s aftera friend mentioned that Gertrude Stein thought we couldmanage very well without commas. We were of a genera-tion whose teachers had given us beat poets alongsideDickens and Eliot so when we opened the Village Voiceevery week to read a column with no trappings of capitalletters or punctuation beyond periods we were open to it,attended to content and found it witty not silly. In New Yorkpublishing at that time we kids just out of college knew howto punctuate but could appreciate purposeful rule breaking.

I picked up a bit of Stein to read to see how she managed.Hers were well formed sentences where sounds and orderhelped me glide from images to thoughts. Reading felt likeswallowing honey. It was easy and intuitive and left meopen to surprises in content. I’m not remembering pigeonson the grass alas or a rose is a rose but rather the ToklasAutobiography and bits of Stein’s writing on writing.

Stein’s sentences invited critical thinking about punctua-tion and grammar. Minimalism was more than a moderniststylistic trick it was a discipline to ensure words were use-ful and structure optimal. Punctuation was no quick fix forlame clauses with nested afterthoughts however correctlymarked up they might be.

Reading Stein herself makes the point better, but theInternet gives me few examples available open access torecommend. Someone must still sit on copyright. Onlyexcerpts quoted by others: a wonderful article by film-maker and feminist academic Kay Armatage (2007) [1] onStein’s attitude toward sentences is a good place to start.Armatage expresses the same feelings I remember thatStein’s writing on writing combines thoughtful liberationexploration and good sense. Some of the quotes Armatageprovides give the flavor of Stein’s owns sentences betterthan my imitations can:

On names and nouns:People if you like to believe it can be made by theirnames. Call anybody Paul and they get to be a Paulcall anybody Alice and they get to be an Alice.

That is the reason that slang exists it is to change thenouns which have been names for so long.

On editing:Of course the first thing that anybody takes out ofanybody’s writing are the adjectives.

On how commas weaken writing:A comma by helping you along holding your coat foryou and putting on your shoes keeps you from livingyour life as actively as you should lead it . . . the useof them was positively degrading.

A longer quotation from Stein on commas was available on

a US community college support website on punctuation

(http://grammar.ccc.commnet.edu/grammar/commas.htm).

It expresses Stein’s main message as I discovered it in the

1970s. Good writing needs few commas. We will under-

stand sentences if the writer has involved us in their content

because knowing that content will ‘force itself’ upon us:

And what does a comma do, a comma does nothing

but make easy a thing that if you like it enough is

easy enough without the comma. A long complicated

sentence should force itself upon you, make you

know yourself knowing it and the comma, well at the

most a comma is a poor period that lets you stop and

take a breath but if you want to take a breath you

ought to know yourself that you want to take a breath.

It is not like stopping altogether has something to do

with going on, but taking a breath well you are

always taking a breath and why emphasize one breath

rather than another breath. Anyway that is the way I

felt about it and I felt that about it very very strongly.

And so I almost never used a comma. The longer, the

more complicated the sentence the greater the num-

ber of the same kinds of words I had following one

after another, the more the very more I had of them

the more I felt the passionate need of their taking care

of themselves by themselves and not helping them,

and thereby enfeebling them by putting in a comma.

So that is the way I felt about punctuation in prose, in

poetry it is a little different but more so …

Gertrude Stein, from Lectures in America

Would Gertrude concede that punctuation is a little differ-

ent but more so in medical texts too? She didn’t have to

deal with strings of odds ratios, confidence intervals and

the like and alas feel a need for all the punctuation she

could get. But the crux of Stein’s lesson transcends genres:

that well chosen words in good order will be all the

stronger if we weed out some of the clutter that obliges us

to use commas.

Mary Ellen KeransBarcelona, [email protected]

Reference:

1. Armatage K. Gertrude Stein’s radical grammar. The Walrus. 2007; February.

(Cited 27 March 2007.) Available from:

http://www.walrusmagazine.com/print/language-gertrude-steins-radical-grammar/

Gertrude Stein on degrading commas in the prose alas



63

by Mary Ellen Kerans

What’s a comma—just an apostrophe that’s fallen low,

right? Wrong. These little specks of ink on a page are a far

more potent defining element of your cultural identity than

you think. Take English and German, for example. When I

hear the word ‘comma’, I smile. Not so when I hear the

word ‘Komma’. This is because, when I write English, the

comma offers itself as a charming and useful option to

make my text more readable. I can flirt with an English

comma. A German ‘Komma’ is a much more serious thing.

It hovers over a sentence at the prescribed place, and you

ignore it at your peril.

To a certain extent, my reaction is an artefact harking back

to school days. German spelling and punctuation rules used

to be a mirror of the Germanic mind-set: authoritarian, log-

ical (more or less), and rigidly enforced. We spent hours

learning where to place ‘das Komma’ or taking down oral

dictation to practice spelling. In the upper forms, bad

spelling and punctuation could lower your grade by a sub-

stantial margin—I shudder to think how many potential

physics and math geniuses´ careers were nipped in the bud

due to their lousy punctuation.

Of course, much of this pedantry does indeed have a

rationale. German words and sentences are, on average,

longer than English ones (ask any translator). There is also

the pesky German habit of sticking verbs at the end of sen-

tences. An English text with sloppy punctuation may be

annoying, but you can usually figure out what the author is

talking about in spite of it. In German, failed punctuation

will almost certainly leave you helplessly marooned in the

text, reading and re-reading a sentence to glean its meaning.

Several years ago, someone decided to ‘reform’ the

spelling and punctuation rules in the German-speaking

countries. Initially, some sensible i.e. logical punctuation

rules were turned into ‘options’ and other spelling and

punctuation rules changed altogether. However, these

changes caused so much upheaval and protest, that the

‘reform’ was ‘reformed’ again, several times, making the

ensuing chaos in everyone’s head and on the page truly

staggering.

The unfolding linguistic anarchy has been interesting, if

not exactly amusing, to watch. We have now reached the

point that at least three national newspapers in Germany

have their own ‘house rules’ for spelling and punctuation.

I find it deliciously ironic that most Germans have com-

pletely given up trying to follow the undulations of these

so-called ‘reforms’ and have relinquished control to their

(American!) Microsoft spell-checker.

In truly Germanic style, these ‘reforms’ were decreed from

above, with an astonishing amount of hubris. What were

the reformers hoping to achieve? Had they really no

inkling of the gargantuan nature of the task they were

undertaking? Had they gone about their job a little more

skilfully, German speakers might have been able to

‘humanize’ their relationship with the once-feared

‘Komma’. Instead, we have a full-blown identity crisis on

our hands, which manifests itself in mutiny on our linguis-

tic flagships.

In contrast to this top-down approach, shifts in language

have a grass roots character in English-speaking countries.

I doubt not that in some distant future we will be writing

‘rite’ and ‘nite’, but no one is going to be obsessing about

it on the way there. English happily absorbs ‘foreigners’

like ‘Kindergarten’ and ‘Angst’ without getting its knickers

in a twist like the French, who have a special committee to

keep the French language ‘clean’. I don’t believe anyone

would dream of setting up a global committee to dictate

new rules for English—can you picture a Brit, an American

and an Australian hotly debating where to place a comma?

No, English speakers will continue to approach punctua-

tion with a sort of breezy lightheartedness that is totally

endearing. You really just have to use some comman sense.

Ursula SchoenbergCreative Communications SolutionsFrankfurt/M, [email protected]://www.sci-tech-specialist.de

Using some comman sense



by Ursula Schoenberg

No sense in missenseAccording to the Oxford Dictionary of Biochemistry andMolecular Biology a missense codon is a codon that has

been altered so that it codes for an amino-acid residue

different from the one for which it normally codes. The

report I was editing, however, referred to Miss Sense

amino acid coding sequences. The dictionary complete-

ly missed this sense.

[email protected]

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IntroductionIn recent years, there has been a great deal of discussion in

the professional press and general media on the need to

restore public trust in our politicians, teachers, doctors—

just to name a few. Five publicly available Reith Lectures

2002, entitled “A question of trust” have been broadcast on

BBC Radio 4, capturing the widespread public mood on

this topic [1].

The loss of public trust in the clinical research community,

particularly in the pharmaceutical industry, came after a

series of allegations focusing on selective reporting of clinical

trial data by the pharmaceutical industry [2,3]. Of particu-

lar concern were instances in which sponsors disclosed

positive results from clinical trials while leaving out the

negative ones. This contributes to publication bias and can

seriously impact the interpretation of data, both at the indi-

vidual study level and for large data sets in meta-analyses

on published studies [4-9]. In an effort to address the situ-

ation, the stakeholders, including the governmental agen-

cies, trade associations, journal editors, the WHO, ICH,

and Cochrane collaboration (Fig. 1), became proactive

regarding the increased transparency of the data on clinical

trials—however without always coordinating or fully

anticipating consequences of their efforts. Unluckily for

those affected in the clinical research community, some of

the proposed or implemented actions by the stakeholders

were conflicting, making compliance towards increased

transparency difficult.

Clinical trial registration and transparency of clinical trials

has been the subject of previous articles in TWS [10,11].

Here we follow up on those reports and summarize some

of the latest developments on this fast-changing topic and

the way these developments potentially affect all patients,

pharmaceutical companies, clinical research organizations,

universities or government institutes, and other individuals

involved in testing of and reporting on investigational

products1 in humans. We also share some of our own expe-

riences gathered while setting up the processes associated

with ‘Clinical Trial Disclosure’ at an internationally ope-

rating pharmaceutical company.

‘Clinical Trial Disclosure’The term ‘Clinical Trial Disclosure’ refers to activities sur-

rounding the public, electronically available registers2 that

are used to present information on i) new clinical trials at

their inception, and ii) results of completed clinical trials.

For this purpose several publicly accessible Internet registers

(repositories of information) that cover all disease areas and

geographical locations and which are open to all sponsors

have been established by non-profit organizations (Fig. 2).

Clinical Trial Disclosure: The ongoing debate on publicregisters for clinical trials



67

by Kathy B. Thomas and Claudia Tesch

1 Investigational products include drugs, biologics, or devices.

2 ‘Clinical Trial Disclosure’ differs from the EudraCT database. The EudraCT database is a compulsory regulatory provision for all clinical trials performed in the European

Union; the information submitted to EudraCT is accessible only to the competent (regulatory) European Authorities. ‘Clinical Trial Disclosure’ implies electronic information

on clinical trials, open to the public free of charge.

3 The US state of Maine has established reporting regulations for all prescription drugs marketed in Maine (State of Maine Law, effective from October 2005), which require all

trials and results of these trials to be registered on a publicly accessible register. Other US states have proposed similar state legislations: California, Hawaii, Michigan,

Minnesota, New Jersey, New York, Pennsylvania, and Rhode Island.

Figure 2: Examples of public registers used for new clinical trials and for trial

results; both registers are repositories. On-line search portals scan

all collaborative registers worldwide (www.ifpma.org;

www.who.int/trialsearch).

Figure 1: Stakeholders in the ‘Clinical Trial Disclosure’



Clinical Trial Disclosure

Legal AspectsAt the legislative level, several US and international incen-

tives have stimulated registration of new clinical trials in

public registers. In the USA, federal law requires, since

1997, the registration of any trial, involving “serious or

life-threatening diseases” (FDA Modernization Act,

Section 113, 1997 [12]). Additional US federal draft bills

and safety acts, as well as state-by-state3 laws have been

introduced and debated at various legislative levels, calling

for public disclosure of information for all clinical trials at

their inception and completion (Table 1).

Outside the US, some countries4 have already established

national laws requiring registration of new clinical trials in

public registers; other countries are at the stage of guide-

lines that encourage voluntary disclosure of new trials; in

some countries, institutional review boards/independent

ethics committees require clinical trials to be registered as

a condition for approval. For the European Union specifi-

cally, the European Commission plans to release some ele-

ments of the EudraCT database to the public via

EuroPharm—the Community database on medicinal products.

To date, the guideline (ENTR/CT 6) is at a draft stage and

no final details have been announced.

Pharmaceutical trade associations andAmerican Medical AssociationIn the absence of pertinent legislation, the pharmaceutical

industry has put forward its own recommendations. In

2005, the pharmaceutical trade associations (IFPMA,

EFPIA, JPMA, PhRMA)5 released the ‘Joint Position

Paper’, committing their members to increased transparen-

cy standards and thereby affecting the disclosure of poten-

tially all clinical trials [13]. The American Medical

Association (AMA) published similar recommendations in

their public statement on this topic [14].

Through the ‘Joint Position Paper’, companies involved in

the development of investigational products were encour-

aged “to make public how they will adhere to these stan-

dards”. In response, many companies now have a statement

on their Internet websites regarding their policies on

‘Clinical Trial Disclosure’; the stated policies, however,

differ among the individual companies.

Standards set down by the ‘Joint Position Paper’ are:

– Registration of all new clinical trials (other than

exploratory trials6, e.g. Phase 1) in a free public reg-

istry within 21 days of initiating patient enrollment.

– Disclosure of results for all clinical trials (other than

exploratory trials6) conducted with drugs that are

approved for marketing and are commercially avail-able in at least one country, within 12 months of

study completion (suggested format: synopsis of the

clinical study report according to the ICH E3 guide-

line) (Fig. 3)7. > > >

1997 FDAMA Law, Section 113Register studies with serious or life-threat-

ening diseases and conditions.

LAW

2005 Maine RegulationsRegister all trials; disclose results on all trials

with the product. Publicly disclose …“informa-

tion about clinical trials of …products…that

are or have been FDA-approved for marketing

and are or have been dispensed, administered,

delivered or promoted in Maine”.

LAW

2002 PhRMA PrinciplesDisclose trial results of all hypothesis-test-

ing trials.

GUIDANCE

2005 IFPMA Industry ‘Joint PositionPaper’Register new hypothesis-testing trials and dis-

close trial results from completed trials with

products that are approved for marketing and

commercially available in at least one country.

GUIDANCE

2007 Enhancing Drug Safety andInnovation Act(reintroduced)

Enzi/Kennedy Bill, Waxman-Markey

Register new trials and disclose all trial results.

FACT Act(reintroduced)

Register new trials and disclose trial results

of studies with serious and life-threatening

diseases.

GUIDANCE

2004 ICMJE Editorial 01Register new clinical trials (hypothesis-test-

ing trials) on a publicly available register to

qualify for publishing. Exploratory trials (e.g.

Phase 1) may be excluded from registration.

EDITORIAL

POLICY

2005 ICMJE Editorial 02Register hypothesis-testing trials is a pre-

requisite for publishing. Specify required

20 data fields for an adequate registration.

EDITORIAL

POLICY

2007 ICMJE Editorial 03Register all new clinical trials as a prereq-

uisite for publishing (adopting the expand-

ed definition of required clinical trials by

the WHO).

Allow pre publication of results in a suggest-

ed format and site (abstract or table format

<500 words, posted in the same clinical

trial register where the original registration

resides).

EDITORIAL

POLICY

Table 1: Important events for ‘Clinical Trial Disclosure’



69

Clinical Trial Disclosure> > >

International Committee of MedicalJournal EditorsIn September 2004, and again in June 2005, the

International Committee of Medical Journal Editors

(ICMJE) announced an unprecedented editorial publica-

tion policy. As a prerequisite for publication, the policy

required authors or sponsors to submit new clinical trials

(excluded at that time were preliminary trials e.g. Phase 1) in

a public register at, or before, the time of patient enrollment

(effective from September 2005) [16,17]. The ICMJE policy

specified criteria for acceptable registers as well as for a min-

imal set of information that would need to be disclosed. Trial

registration with missing fields or fields that contain uninfor-

mative terminology would be considered inadequate.

In their latest editorial (June 2007), the ICMJE expanded

its definition of clinical trials [adopting to the World Health

Organization (WHO) definition], requiring all clinical trials

(including preliminary trials e.g. Phase 1) to be registered

so as to qualify for future publication [18]. The editors said

they were expanding the definition of trial types that must

be registered to include preliminary trials in the public

domain. This latest policy comes into effect for clinical trials

starting on or after July 2008.

In addition, the updated policy states that ICMJE will not

consider a posting of results as “pre publication” only if

it is structured as an abstract or a table not exceeding

500 words—and posted in the original registry where the

study was registered [18]. This could imply that results dis-

closure would occur on www.clinicaltrials.gov and not on

PhRMA’s www.clinicalstudyresults.org.

Many other journal editors have adopted the recommenda-

tions of ICMJE on publication policy. Indeed, since the ini-

tial announcement of their publication policy on clinical

trial registration in a public register in 2004, a substantial

number of other journals accepted the ICMJE Uniform

Requirements for Manuscripts standards. A link to the list

of these journals can be found on the ICMJE homepage or

by checking the ‘Instruction for authors’ for the journal of

interest.

Registers for new clinical trialsCurrently, the largest and most commonly used interna-

tional clinical trial register is the www.clinicaltrials.gov. It

was created following the enactment of the FDA

Modernization Act of 1997, and is operated by the US

National Library of Medicine of the National Institutes of

Health. The register fulfills the criteria specified by ICMJE

and the ‘Joint Position Paper’. Other acceptable registers

are summarized elsewhere [18,19].

Originally, the www.clinicaltrials.gov register was intend-

ed to help patients and their physicians locate clinical tri-

als in which to enroll. However, due to recent develop-

ments in clinical trial disclosure, the register serves many

other users such as journal editors, granting agencies, the

research community, ethics committees, and institutional

4 Mandatory registration of new clinical trials in national public registers: Israel, Italy, South Africa, Taiwan.

5 For abbreviations see Table 2; for important websites see Table 3.

6 Exploratory trials “serve to set direction (i.e. to generate hypothesis) for possible future studies” [13].

7 If a peer-review journal publication for a particular study is announced, an additional 12 months is granted for an interim period as a round-about to allow for the journal edi-

tors’ review and approval process [15] (Fig.3).

Table 2: Abbreviations

Table 3: Important Websites

AMA American Medical Association

CRO Contract Research Organization

EFPIA European Federation of Pharmaceutical Industries and

Associations

EudraCT European Clinical Trials Database

FDAMA Food and Drug Administration Modernization Act

ICH International Conference on Harmonisation

ICMJE International Committee of Medical Journal Editors

ICTRP International Clinical Trials Registry Platform

IFPMA International Federation of Pharmaceutical

Manufacturers and Associations

ISRCTN International Standard Randomised Controlled Trial

Number Register

JPMA Japanese Pharmaceutical Manufacturers Association

NIH The US National Institutes of Health

PhRMA Pharmaceutical Research and Manufacturers of America

UTRN Universal Trial Reference Number

WHO World Health Organization

FDA Modernization Act

of 1997 Section 113

(FDAMA)

http://www.fda.gov/cder/guidance/4856f

nl.htm

ICMJE http://www.ICMJE.org

Joint Position Paper http://clinicaltrials.ifpma.org/

PhRMA http://www.phrma.org/clinical_trials/

Registers Hosted by National Institutes of Health

http://clinicaltrials.gov/

Hosted by ISRCTN

http://www.controlled-trials.com/isrctn/

Hosted by PhRMA

http://www.clinicalstudyresults.org/

IFPMA search portal http://clinicaltrials.ifpma.org/

WHO search portal http://www.who.int/ictrp/en/




review boards [5,19]. By May 2007, more than 40,000 trials8

had been registered; for the industry, 1,054 pharmaceutical

companies and Clinical Research Organizations posted

information on 14,786 clinical trials, of which 5,788 were

in the process of recruiting patients.

The register www.clinicaltrials.gov represents a wealth of

information on clinical development. The site is easily

accessible, with consistent, user-friendly, and focused search

possibilities (by disease, location, age group, study phase, or

sponsor). For registrants, clear on-line instructions show

how to register a new clinical trial; uncertainties and ques-

tions are promptly answered by the helpdesk staff [19,20].

Registers for completed clinical trials (disclosure of clinical trial results)Although the disclosure of clinical trial results is required

by law only in the US State of Maine3, many companies

disclose clinical trial results voluntarily. This is partly

because of the commitment of the pharmaceutical trade

association and its members, partly due to individual compa-

nies’ own declared transparency policies, and partly due to

continued pressure from the professional media [18,20,21].

Some companies disclose clinical trial results on their com-

pany’s websites (e.g. Boehringer Ingelheim, Forest

Laboratories, Eli Lilly, Merck, Novartis), while others use a

third party vendor (Roche), or the publicly available register

www.clinicalstudyresults.org hosted by PhRMA.

By May 2007, more than 60 pharmaceutical companies

have used www.clinicalstudyresults.org (e.g. ALTANA

Pharma, Sanofi-Aventis). It is a central, widely accessible,

web-based register for clinical study results. The database

contains the results from “hypothesis-testing” clinical studies

(mainly Phase III and IV studies) completed since October

1, 2002, largely for drug products that are approved in the

United States (although in recent years results on drugs

with non-US approval are also being posted on this site).

Results of studies include both published articles and

unpublished study summaries.

At present, there is no formal consensus on international

norms and standards for results reporting. The format of

disclosed entries differs even at an individual company

level. Many entries are scanned documents, which pre-

cludes electronic search. Because of the way the register is

organized, the number of individual entries is difficult to

assess, as this would require manual counting.

The implementation dates suggested by the ‘Joint Position

Paper’ for results disclosure is “within one year after the

drug is first approved and commercially available in any

country, or for trials completed after this initial approval,

within one year of trial completion, unless such a posting

would compromise publication in a peer-review journal”.

One of the implications of this statement is that in order to

comply with that request, clinical studies conducted with

commercially available products will require tightly coordi-

nated efforts on the part of clinical departments, investiga-

tors, biostatisticians, medical affairs, and medical writing.

Publishing a study in a peer-review journal is an important

goal for all involved. If timely publication is not realistic,

study results should be released in a format such as that of

the ICH E3 summary [13]. An alternative way to present

clinical trial results without compromising future publica-

tion of the original data in a peer-review journal has been

proposed by the ICMJE (see section above on the ICMJE

editorial June 2007) (Fig. 3).

In addition to the above recommendations regarding the

disclosure of clinical trial results, recent regulatory require-

ments by the European clinical trials directive (ENTR/CT2,

2006) specify the conditions for the disclosure of clinical

study results to the ethics committees, competent authori-

ties, and the clinical investigator responsible, as follows:

“At the end of the trial (on all sites in a multi-centre trial)

the sponsor should provide the ethics committee with a

summary of the clinical trial report. To be responsible for

his/her part in the report writing, the investigator should

have access to the recorded and reported data to ensure

accuracy, completeness and timeliness. This report should be the

same as the one forwarded to the competent authority…” [22].

For the EU countries, at least, this should encourage con-

cordant disclosure of results to all parties mentioned by the

regulatory guidance, as well as to the public registers.

Overall, it is clear however, that when it comes to the dis-

closure of clinical trial results there are still numerous open

issues that need clarification, agreement, and commitment

by all stakeholders [20].

WHO and the universal trial reference number Several different public and non-public registers of clinicaltrials exist. Some contain information only on new clinicaltrials; others contain results of completed trials, and stillothers contain both. Some registers operate internationallyand others at a national level; some are run by non-profitothers by for-profit organizations. This means that there aremany registers available which can (and does) lead to mul-tiple entries of the same clinical trial in different regis-ters—a situation that should be avoided because it is mis-leading and lowers the credibility of the registers.

To reduce duplication of entries, facilitate unique identifica-tion of clinical trials, and promote transparency, theInternational Clinical Trials Registry Platform, based atWHO, has announced on their website the allocation of a uni-versal trial reference number (UTRN). It is planned that sucha number will be available soon and shall be used to track allactivities of a particular trial, including the study protocol,ethics committee’s advice, regulatory submission documents,posting of results and journal publications [23,24].

8 The unwary user performing a search of the www.clinicaltrials.gov register please note that only the ‘recruiting’ trials appear automatically; a box in the top left screen has to

be checked to also view trials that are ‘no longer recruiting’.

> > >



71

Clinical Trial Disclosure> > >

Universal search portals for registersIFPMA and WHO provide on-line portals, which searchthe collaborative primary registers worldwide, thus, pro-viding a single point of access to information about ongo-ing and completed clinical trials (www.ifpma.org;www.who.int/trialsearch).

Our experiences and recommendationsFrom our own experience, the implementation of the‘Clinical Trial Disclosure’ in a pharmaceutical companyrepresents a challenging but very exciting set of tasks. Thejob requires knowledge of the latest relevant regulatorylaws and guidelines, their sources, and applicability. In ourcase, the tasks were cross-functional, inter-departmental,inter-continental, and very communicative at all stages. Forsomeone getting involved in this field, we suggest to keepthe following points in mind:

1. Inform upper management (corporate level) about therequirements and implications of the ‘Clinical TrialDisclosure’ tasks; ensure commitment from uppermanagement for the project.

2. Assign a responsible person/group of persons(‘Clinical Trial Disclosure Managers’) to coordinateactivities of the project and integrate all involvedfunctions and departments in the decision-making(clinical, clinical affairs, legal, intellectual property,regulatory, public relations, medical writing).

3. Establish company guideline(s), with a ‘decision tree’for responsibilities and processes.

4. Include all clinical trials from all subsidiaries.5. Establish agreements regarding the responsibilities

with co-developing and marketing partners, as well aswith investigators (multicenter trials, investigator-ini-tiated trials).

6. Insist on reliable information of planned new trialsand completed trials.

7. Coordinate the preparations to register a new clinicaltrial with the review and approval of the clinicalstudy protocol.

8. Coordinate the preparation of the results disclosure with

the review and approval of the clinical study report.9. Consider publication strategy soon after the study

outcome is known.

10. Establish a procedure for updating entries in the pub-

lic registers.

11. Establish a procedure for responding to public

enquiries (e-mail, phone).

12. Maintain a sense of humor!

ConclusionsRestoring public trust in the clinical research community is

the most important aim of the ‘Clinical Trial Disclosure’.

This is a complex task and it is up to all stakeholders to

realize the aim without excessive or uncoordinated regula-

tions. There is still plenty of work to do to restore public

trust by sensibly coordinating and harmonizing the various

proposals designed to increase transparency and accounta-

bility. Pharmaceutical companies, which have been at the

center of attention for not being trusted, are overwhelming-

ly responding to the new requirements, guidelines, and

suggestions. For those involved in, and affected by, the

‘Clinical Trial Disclosure’ it is indeed no longer a matter of

‘whether’, but rather ‘when’ and ‘what’ to disclose. The

debate on public registers for clinical trials is definitely

going on.

Affiliations/Competing interestsKathy B. Thomas and Claudia Tesch are employees of

ALTANA Pharma (Member of the Nycomed Group), loca-

ted in Konstanz, Germany. Both are medical writers and as

part of their tasks they coordinate entries for registers (new

clinical trials and results of completed trials) applicable to

the ‘Clinical Trial Disclosure’. Both have presented the

topic regularly to company internal audiences and actively

participated in several external meetings.

Figure 3: Proposed timelines for posting information on new clinical trials

and results of completed clinical trials on public registers.




GSK experience firstconsequences of a studyresults databaseGlaxoSmithKline which has a very extended results reg-

istry has experienced the first consequences of these

databases. Data from GlaxoSmithKline’s study results

database have been used by independent scientists for a

meta-analysis that has just been published in The NewEngland Journal of Medicine (NEJM). The meta-analysis

is entitled ‘Effect of Rosiglitazone on the Risk of Myocardial

Infarction and Death from Cardiovascular Causes’ and was

conducted by Steven E. Nissen and Kathy Wolski

(http://content.nejm.org/cgi/content/short/NEJMoa072761

?resourcetype=HWCIT ).

This analysis found that the diabetes drug rosiglitazone

manufactured by GSK significantly increases the risk of

myocardial infarction. The study was limited by a lack

of access to original data source data which the authors

state would have allowed a time-to-event analysis. The

authors conclude that

“The manufacturer’s public disclosure of summary

results for rosiglitazone clinical trials is not sufficient

to enable a robust assessment of cardiovascular risks.

The manufacturer has all the source data for com-

pleted clinical trials and should make these data

available to an external academic coordinating cen-

ter for systematic analysis. The FDA also has access

to study reports and other clinical-trial data not with-

in the public domain. Further analyses of data avail-

able to the FDA and the manufacturer would enable

a more robust assessment of the risks of this drug.”

Three editorials accompany the report in the NEJM. It

has caused concern among doctors and diabetes patients

and it has been suggested that it will involve the US

Federal Drug Agency in a new scandal.

On 16th June 2007 The Economist reported that GSK’s

shareholders have brought a lawsuit against the company

for failing to adequately disclose the studies it had con-

ducted into rosiglitazone.

For more information about the drug see http://search.med-

scape.com/all-search?queryText=rosiglitazone


The following boxes are also relevant to clinical trial disclosure:

‘500 words is not enough’ (page 51) and ‘The PPP Survey’ (page 92).

AcknowledgementWe thank our colleagues Dr. Angela Schilling (ALTANA

Pharma, Member of the Nycomed Group, Medical Writing

Department, Konstanz, Germany) and Dr. Art Gertel (VP,

Clinical Services, Regulatory, & Medical Writing,

Flemington, NJ, USA) for valuable comments during the

preparation of this article.

Kathy B. Thomas and Claudia TeschALTANA Pharma (Member of the Nycomed Group), Konstanz, [email protected]; [email protected]

References:

1. O’Neill, O. Reith lectures 2002 - A question of trust.

http://www.bbc.co.uk/radio4/reith2002/; accessed June-2007.

2. Bloch D, Dennis A. Disclose, but what to expose? Scrip Magazine 2005;

March: 24-25.

3. Steinbrook R. Registration of clinical trials - voluntary or mandatory? N Engl JMed 2004; 351: 1820-1822.

4. Korieth K. Clinical trial transparency efforts multiply. CenterWatch 2005; 12: 1-13.

5. Godlee F. An international standard for disclosure of clinical trial information.

BMJ 2006; 332: 1107-1108.

6. Armstrong D. Financial ties to industry cloud major depression study. The

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7. De Angelis CD. The influence of money on medical science. JAMA 2006; 296:

996-998.

8. Irwin RS. Clinical trial registration promotes patient protection and benefit,

advances the trust of everyone, and is required. Chest 2007; 131: 639-641.

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published trials of drug-drug comparisons: why some statins appear more effi-

cacious than others. PLoS Medicine 2007; 4: e184.

10. O’Halloran R. Transparency in disclosure of clinical trial information. TheWrite Stuff 2006; 15: 15-17.

11. Wager E. Trial registration: What do writers need to know? The Write Stuff2006; 15: 13-14.

12. Food and Drug Administration Modernization Act of 1997 (FDAMA). 105-115.

1997. Pub/L No. http://www.fda.gov/cdrh/modact97.pdf; accessed June-2007.

13. EFPIA, IFPMA, JPMA, and PhRMA. Joint position on the disclosure of clini-

cal trial information via clinical trial registries and databases. www.ifpma.org.

2005; accessed June-2007.

14. American Medical Association. Council of Scientific Affairs. Influence of

funding source on outcome, validity, and reliability pharmaceutical research

(A-04). www.ama-assn.org 2004; accessed June-2007.

15. PhRMA. PhRMA Clinical Study Results Database Proposal. www.phrma.org.

2003; accessed June-2007.

16. De Angelis C, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, Kotzin S,

Laine C, Marusic A, Overbeke AJ, Schroeder TV, Sox HC, Van Der Weyden

MB. Clinical Trial Registration: A Statement from the International Committee

of Medical Journal Editors (editorial). N Engl J Med 2004; 351: 1250-1251.

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Laine C, Marusic A, Overbeke AJ, Schroeder TV, Sox HC, Van Der Weyden

MB. Is This Clinical Trial Fully Registered? — A Statement from the

International Committee of Medical Journal Editors (editorial). N Engl J Med2005; 352: 2436-2438.

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C, Hebert PC, Kotzin S, Marusic A, Sahni P, Schroeder TV, Sox HC, Van Der

Weyden MB, Verheugt FWA. Clinical trial registration. Looking back and

moving ahead (editorial). JAMA 2007; June 4: E1-E2.

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registration of clinical trials. JAMA 2007; 297: 2112-2120.

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www.who.int/ictrp/registration/; accessed June-2007.

How it all startedI first heard about the Norwegian-Russian Centre for

Medical Studies from a Norwegian professor in radiology,

Frode Lærum, who had the idea that started it all. He want-

ed to help Russia maintain good scientific functions after

the Soviet Union collapsed in 1993, and to help avoid a

complete brain drain to the United States and other coun-

tries in those difficult times. A cooperation agreement

between the Russian Academy of Sciences (RAS) and the

University of Oslo was signed in Moscow 30 June 1993, an

event covered by Russian television. The Norwegian broad-

casting company’s correspondent in Moscow, journalist and

historian Hans Wilhelm Steinfeld, became one of the mem-

bers of the first board. Steinfeld gained international recog-

nition for his interviews with Gorbatsjov, Jeltsin and prime

minister Rysjkov in the period 1991-1994.

The Centre has financed 168 researcher working years at

the Institute of Gene Biology and the Engelhardt Institute

of Molecular Biology at RAS since 1993. The fellows have

published 184 articles during the past 13 years, quite a few

of them in acknowledged western journals such as Nature,Science and Cell.

Co-operation in practiceSymposia have been important educational and networkingoccasions for the Centre and an equal-basis cooperationhas been emphasized to facilitate efficient transfer ofknowledge. A Russian and a Norwegian Programme plan-ning Committee are responsible for each symposium. The

aim is to have an equal number of Russian and Norwegianpresentations. About half of the 50 symposia that havebeen arranged since 1993 have been joint ventures withSechenov Medical Academy, the Centre’s major medicalpartner and Russia’s oldest and largest medical university.Topics have varied from laparoscopic surgery and healthlegislation to medical ethics and oncology. More than10,000 Russian physicians, nurses and other health person-nel have attended the symposia-programme so far, andapproximately 400 Scandinavian and West-European spe-cialists have presented their lectures in Russia. Russian andEnglish programmes and abstract books have been pub-lished for each symposium. It is a goal to keep costs low,so none of the invited lecturers to the symposia receive anyfinancial compensation.

The Centre has a diverse programme for specialistexchange. There is an ongoing collaboration on mini-inva-sive surgery with the Moscow State University ofMedicine and Dentistry, the Sechenov Academy and theInterventional Centre at the National Hospital (Rikshospitalet)in Oslo. An interesting aspect of this collaboration is thatthe Interventional Centre has bought some practical equip-ment for mini-access liver surgery from Russian colleaguesin Yekaterinburg. Professor Babill Stray-Pedersen atRikshospitalet, Oslo (WHO’s European advisor for repro-ductive health in their Scientific Technical Advisory Group[STAG]) plans to develop locally adapted guidelines forreproductive heath and birth care for the St. Petersburg areain cooperation with the Regional Clinical Hospital of St.Petersburg (if the application I sent 15 April this year is suc-cessful). Haematological diseases, drug abuse, urology,management and health legislation are other topics of col-laboration with Russian hospitals and Universities.

There are large differences in competence within theRussian health system; some groups are fully at height withwestern university standards, while others are far behind.The aim from the start was to cooperate with those of amiddle-standard, but also to learn from environments withmore expertise. Their fields of expertise are typically thoseassociated with areas that were of special interest to theSoviet Union; such as defence and space technology andprotection against radiation.

Equality and reciprocity are more and more replacing theformer humanitarian profile, and the Centre’s activitiesreflect the interest not only of the Russians but also of theNorwegian partners. Only those projects where all partiesinvolved feel they have something to win are likely to suc-ceed.

Saving a brain drain: The Norwegian-Russian Centre forMedical Studies and a medicalwriter’s role in grant applications



73

by Kari Skinningsrud

The initiators and fundingProfessor Sjur Olsnes, an acknowledged researcher at

the National Cancer Hospital in Oslo, had kept in touch

with fellow researchers in the Russian Academy of

Sciences since he worked there for the renowned profes-

sor Engelhardt in 1968. Olsnes has been a key partner

for Lærum from the Centre’s beginning, and so has

Olsnes’ good friend and colleague from RAS, professor

Jurij V. Kozlov. In 1996 the staff in Oslo was increased

with a Russian-speaking project manager, Julia Ferkis,

who has been responsible for administration of the

Centre since. The Centre’s main grant providers are the

Norwegian Ministries of Foreign Affairs, Health and

Education and Research, totalling 625,000 euros.

The medical writer’s roleSo, how did I become involved? Professor Lærum was the

principal investigator in the first clinical study I was

responsible for in Nycomed Imaging many years ago.

When he visited Nycomed in 2001 to tell us about the

Centre for Norwegian-Russian Medical Studies, I gave him

my card and told him I was

about to become a freelance

medical writer. The years

passed, I forgot all about hav-

ing given my card to him, but

in 2005 he contacted me and

said he had a job for me.

They needed help to write

applications for funding. At

first I wondered if that was

something a medical writer

could do, as it had not been mentioned in any EMWA

course I had heard about, and I had never actually written

such an application myself. After a meeting with the three

people working at the Centre at Rikshospitalet (administra-

tive head, professor and secretary), I started to work for

them as a freelancer two days a week from March 2005.

Involving an external writer in the process of applying for

funding was an arrangement new to all implicated person-

nel, and practical approaches suitable to each individual

team were sought. My contribution varied from brushing

up the language to writing most of the project description,

all according to time available and wishes from the teams.

I also spent some time trying to find funding sources. My

engagement expired after 7 months. The Centre decided to

see if the applications I had

assisted with generated fund-

ing before they considered

renewing my contract. It had

been quite controversial to

pay someone to write appli-

cations, and it was necessary

to give the senior UiO man-

agers some proof of the use-

fulness of my work before it could continue. It turned out

that quite a lot of money was granted from the applications,

so I was invited to come back—to be employed half-

time—and I continued to work for them from September

last year.

I had the interesting experience of giving a course on grant-

writing to the Centre’s researchers in Moscow for two days

in March this year. The process of preparation was valuable

for my own work, and looking at notes from EMWA work-

shops I have taken was really useful, even though none of

them were on grant-writing. The main theme of the course

was translating ideas into projects and selling them to dif-

ferent target groups. I understand that writing an applica-

tion for funding is quite often the first attempt to describe

the research idea in writing, i.e. structure the work process,

define areas of cooperation, write objectives, endpoints,

milestones and measurements and plan timelines and

budgets. It was challenging for me to speak to people who

do basic research and find relevant examples of endpoints

etc. It is very different from doing clinical studies, but

planning a project is still quite generic and many aspects of

protocol writing and quality control are relevant in basic

research as well. All project descriptions should spell out

clearly why the methods and endpoints are the best ones in

that specific context and why the variables measured are

appropriate in relation to the stated objectives. Quality

assurance measures should be included to ensure that the

data produced will be reliable and accurate, even if and

especially because GLP is not required in basic research.

There have been some articles about grant-writing in the

past issues of TWS. However, when I offered a short work-

shop on this topic for EMWA’s Vienna conference only a

few delegates were interested in joining the course. I am

convinced that grant-writing is a field where medical writ-

ers have great opportunities and can make substantial con-

tributions, but we still have a job to do to alert medical

writers to this potential and

convince those who apply for

grants that it is worth paying

a medical writer (and not just

anyone) to do it.

My job in the Centre for

Norwegian-Russian Medical

Studies is rewarding in many

ways. I have experienced that my years in the pharmaceu-

tical industry have given me competence that is welcomed

in arenas where I did not think I would have anything to

contribute with. The work I do in the Centre is also reward-

ing in the sense that I meet many grateful researchers who

have never been offered any help with applications and

who appreciate the collaborative process in itself. It was

good to hear one of the more experienced researchers in

Moscow express her gratitude to Norway and the Centre

for Norwegian-Russian Medical Studies for helping them

in difficult times, and to continue to do so in times that are

still not easy.

Acknowledgement Much of the information in

this article is taken from

the Centre for Norwegian-

Russian Medical Studies’

annual reports from 2005-06,

written by the Centre’s

administrative head Julia

Ferkis.

Kari SkinningsrudLillestrøm, [email protected]



Saving a brain drain

Professor inradiology, Frode

Lærum, wanted tohelp Russian

scientists after theSoviet Union

collapsed

Only projects whereall parties feel theyhave something to

win are likely tosucceed

I am convinced thisis a field wheremedical writers cangive substantialcontributions

“The scientific importance of English is such that, whenever Ihave a meeting with my residents—and I have many, both res-idents and meetings—I find myself emphasizing, over and overagain, the need for them to learn English.” [1]

(Dr Javier Lucaya, Chairman of Radiology, Vall d’Hebron,Barcelona)

Five years ago when visiting an English family member inthe reference hospital for the Balearic Islands, Son DuretaHospital, I recognised the enormous necessity for English forMedical Purposes, as stated above by Dr Javier Lucaya. DrLucaya later says: “I may be exaggerating….” He is not. Heis understating. English is essential at all levels of the healthsystem in Spain for communication with the enormous influxof foreign visitors taking vacations in the country in summer.Doctors must also write articles in English for internationaljournals and take part in conferences held in English toadvance in their careers. Needs were there, but were notbeing addressed. I saw an opportunity to merge my interestsin teaching and medicine and begin to fill this gap.

Jim Scrivener [2] notes that there are three kinds of teacher:the explainer, the involver and the enabler. I see myself as thelast of these three. Scrivener states, “This kind of teacher isconfident enough to share control with the learners, or to handit over to them completely”. Carl Rogers, an American psy-chologist (1902-1987), considered authenticity to be the mostimportant characteristic for a teacher [2]. It is vital to be your-self, and not the ‘teacher’, and to build up a rapport with thestudents. I agree with both. I try to share control and be myself.When I start a course, the first thing I say is: “I am the teacherand the student, and you are the students and the teachers. Myaim is to teach you English and I hope to learn about your dif-ferent specialities”.

I started teaching at Son Llatzer Hospital on Majorca in2003. It is a provincial hospital, with in the region of 400beds and not all the specialities. I had the great luck to beginworking there about 6 months after its inauguration and wastherefore there from the beginning. I taught groups of 25, andvery often, especially with the low levels, I needed to givethem grammar lessons. But even at the low levels I madethem give ‘presentations’. The groups were very mixed.There were doctors, nurses, auxiliary nurses, pharmacists,porters, lab technicians, computer staff, receptionists, andadministrative staff. This enormous variety of people allworking in the same hospital was a great advantage both forme and for them. The classes were a way of allowing hospi-tal staff to interact, who in the normal course of events wouldnot do so. Hospitals are very cliquey places, and porters donot often have the possibility to speak to the head of thePsychiatric Department.

You can never ‘learn’ a language, but you can develop yourknowledge to a sufficient level to be able to achieve differentthings such as speak to patients, give an explanation of illnessto the mother of a sick boy, give directions to a lost relative,or give a presentation to the American Society of Nephrology.

I have since focussed on teaching in particular departments,such as ENT, Gynaecology, Paediatrics, or Dermatology. Ihave continued with the presentations, as they are integral tothe life of a doctor. My students give ‘talks’ in the classes,later to be criticised by me, for the linguistic content and bytheir peers for the scientific content. They learn from meabout the use of the definite article and I learn from themabout ‘dermoscopy of pigmented facial lesions’.

In 2005, the ENT Department of Son Llatzer Hospital gavea symposium about the importance of image-guided surgery.Originally the meeting was going to be conducted in Spanishwith me interpreting, but I suggested that they should givetheir talks in English. It seemed the ideal situation, and itworked well. I sat at the front of the lecture hall and tooknotes on my students. The following day I went into classand explained where they had slipped up with their use oflanguage and pronunciation.

As readers of this article you might begin to think that I havemisled you with the title. I have talked about my experiencesas a teacher of English to members of the medical profession,but where does the subtitle come in? Isn’t bringing thehumanities to medicine seemingly an oxymoron?

I have no medical training, but the medical world fascinatesme. I am drawn to it, but my training is in the arts, thereforemedicine is a field I find difficult. Many people are interestedin both arts and science, but there is a crucial difference. Ifyou study the sciences, you can delve into the arts, but theopposite is not really true. This is why I have been drawn toa speciality called the ‘Medical Humanities’.

This speciality was given two formulations by the then edi-tors of the journal of the same name [3]:

“The first is concerned with complementing medical scienceand technology through the contrasting perspective of thearts and humanities, but without either side impinging on theother. The second aims to refocus the whole of medicine inrelation to an understanding of what it is to be fully human;the reuniting of technical and humanistic knowledge andpractice is central to this enterprise. We have described thesetwo approaches to medical humanities as “additive” and“integrated” respectively.”

This field is little known in Spain, even amongst doctors. Ithas been around for a lot longer in the USA and the UK, andis part of the medical training in many universities, such as

Teaching English to the medical professionDeveloping communication skillsand bringing humanities to medicine



75

by Jonathan McFarland



Teaching English to the medical profession

New York University, University of Texas, and UniversityCollege, London. It is not an easy discipline to integrate intothe courses in hospitals, but since the beginning it has infil-trated into my teaching, both in content and in style.

I have tried to instil it into my courses in more concreteways, especially since 2005 when I began to teach at SonDureta Hospital, where the groups have been smaller, andmore focussed on the clinical side of medicine. In relation tothe above quotation, I have made literature prominent intackling the first ‘additive’ point, by using texts with a directinterest to medical professionals, such as Jean-DominiqueBauby’s poignant description of the ‘locked-in syndrome’, orRaymond Carver’s honest poem “What The Doctor Said”,which is an account of the writer’s doctor telling him he haslung cancer [4]1, or Chekhov, himself a physician, who treatsmedical topics with cool precision.

I have used the second ‘integrated’ point—‘an understandingof what it is to be fully human’—as a kind of foil to the evergrowing trend in medicine to specialisation or maybe over-specialisation. In the medical profession it is essential neverto lose sight of the overall picture because if you do, some-times grave errors will arise. I have worked on the ‘patient-centred approach’, with texts, video work and roleplays. Wehave had debates about whether medicine is an art or a sci-ence and on how to break ‘bad news’ to the family. We spenta few weeks working on the ‘art of dying’, and looked at thisfrom many angles: the medical, the ethical, the religious, andthe philosophical. Here, I was indebted to an interesting web-site put together by Kings College, London [5] based on ayear-long symposium addressing a range of questions associ-ated with death and dying.

This term we have begun to work on the question of the roleof the doctor, what they can do apart from curing and caring,and how conversation, can help them to be better doctors. Asa source text, I used the article entitled “How Work can beMade Less Frustrating and Conversation Less Boring” [6] byDr Theodore Zeldin in which he writes

“The healthcare profession contains a vast reservoir ofpotential going to waste, of talents which are not properlyappreciated, and of conversations which never take place.”

The article is directed towards doctors and written for a med-ical journal. It led to essays by my students, with thoseessays being sent to the author and commented on by him,which in turn led to further debate amongst the students. Thiswas a vital experience of opening out the enclosed ‘class-room’, and only became possible with modern technology, e-mails, and web-links. Technology plays its part, but humaninteraction is the core. This on-line conversation between stu-dents and Dr Zeldin is a thread for this year’s course, and per-haps epitomises my ideas about how to try and use thehumanities in a classroom full of scientists.

“Good communication skills are integral to medical andother healthcare practice. Communication is important notonly to professional—patient interaction but also within thehealthcare team.” [7]

This is integral to what I have been trying to install in bothhospitals in Majorca: good communication skills in theEnglish language, both oral and written. I have paid a lot ofattention to the writing of abstracts, articles, presentations

and posters. I have also set writing assignments, the latestbeing a term project concentrating on an idea picked up fromthe British Medical Journal. At the beginning of this year,the journal chose the 15 most important medical milestonessince the first publication of the journal in the 1840s. The top-ics ranged from immunology to the Pill, sanitation to chlorpro-mazine, and smoking to vaccines. First my students had tochoose the topic they thought had made the biggest impact andwrite an essay on it. Then they had to give an oral presentationwith PowerPoint slides on the same theme. In this way theypractised both oral and written communication skills.

As I explained earlier I have always seen presentations or‘talks’ by the students as a way of furthering their ability touse the language and at the same time impart information ofinterest to the rest of us. In June 2006 to conclude the firstyear of the English course at Son Dureta Hospital, accredit-ed by the Local Health Ministry for the Balearic Islands, I setmy students the task of giving presentations in the lecturehall of the hospital. There was a mixture of medical and non-medical topics, “The Eating Disorders Unit” alongside“Photography: A technique to relive a magic instance”, and“News from the lab” next to “Dreams”, with “Popular archi-tecture” combining with “Team building”. It was a fitting cul-mination to a year’s work, but only the beginning of what willhopefully become an annual event in this teaching hospital.

There are many plans for the future, but one is already a real-ity: a translation and linguistic unit has already beenannounced for Son Dureta Hospital, essential for a hospitallooking to be an important contributor in the field of researchand investigation. Soon I hope that English may be the lan-guage for clinical sessions, which may happen sooner thanexpected as I have been asked to attend weekly oncologysessions at Son Llatzer Hospital. These will be held inEnglish and my role will be to give the oncologists feedbackon their English. Another plan is to set up a blog for profes-sionals from different hospitals to communicate with eachother in English. I am beginning to do this with my studentsfrom both hospitals but I think it can be carried further as ameans of inter-hospital communication. My hope is thatEnglish will become an integral part of hospital training andlife. A big hope but attainable.

I wish to dedicate this article to Dr Antoni Obrador (the lateHead of the Digestive Unit, Son Dureta University Hospital),who was a great support in setting up the English course.

Jonathan McFarland Palma, [email protected]

References:

1. Medical English, Ramon Ribes, Pablo Ros, Springer, 2006.2. Learning Teaching, Jim Scrivener, Macmillan Heinemann, 1994.3. Medical Humanities Online: http://mh.bmj.com/ 4. What The Doctor Said, Raymond Carver: http://judithpordon.tripod.com/poet-

ry/raymond_carver_doctor.html5. Kings College, London – Art of Dying:

http://www.kcl.ac.uk/phpnews/wmview.php?ArtID=247 6. How Work can be Made Less Frustrating and Conversation Less Boring,

Theodore Zeldin, BMJ: http://www.bmj.com/cgi/content/full/319/7225/16337. Communication Skills Education for Doctors: An Update. November 2004.

Board of Medical Education of the British Medical Association:http://www.bma.org.uk/ap.nsf/AttachmentsByTitle/PDFcommunicationskillsupdate/$FILE/communication.pdf

1 After writing his last story, “Errand”, about Chekhov’s death, Carver learned that he

had cancer.

Often when you accept a medical writing job you begin the

task by researching the therapeutic area concerned. This

can mean a quick update to remind you of any changes, or

researching for several days to try to get a feel for a new

disease area. I often employ an additional method, which is

effective, does not involve delving into text books, or surf-

ing the net, and feels much less like ‘work’. Perhaps you

already use it?

A while ago I found myself writing a couple of hundred

very detailed case narratives for Parkinson’s disease. For

large phase III studies this can involve trawling through

many hundreds of pages of listings to extract key data

points to populate narratives. In this instance, considering

the amount of information required by the client, each nar-

rative was taking over three hours to write, contained

masses of information about drugs with unknown names,

and procedures that were not familiar to me.

Writing narratives can be a very laborious exercise, and

unsurprisingly deal with many negative aspects associated

with a disease area. For me, to keep the task invigorating it

can help to put the disease in context, not just from a sci-

entific perspective, but also from a patient perspective.

To help me understand Parkinson’s disease from a patient’s

view I began to read ‘Lucky Man: A Memoir by Michael J.

Fox’ In his autobiography he deals with his career and also the

discovery that he had young onset Parkinson’s disease [1].

He describes the symptoms of the disease first hand, writ-

ing, “Every time my most recent dose of Sinemet would

wear off the disease presented me with a concise history of

my symptoms—first the tapping of the pinkie, then the

dancing hand, and within fifteen minutes or so, the whole

of my left arm would be tremoring. Tremoring, actually, is

too subtle a word—the tremor would start my whole arm

bouncing.” This kind of detailed description brought to life

the ‘increase or worsening of tremor’ written in a listing as

an adverse event.

Concomitant procedures undertaken during the course of

the trial were also listed and in the book he describes hav-

ing to undergo ‘thalamotomy’ providing a very detailed

description of exactly what the procedure involved. This

was no longer just a word written in a listing, and given a

definition by a medical dictionary, but a complex proce-

dure that patients underwent in an attempt to increase their

quality of life.

In 1986 when I was investigating HIV-1 for my PhD, many

new scientific discoveries were being made about a recent-

ly isolated virus. There were no licensed antiretroviral

treatments and the outcome for those infected with the

virus was considered dire. The media was full of extreme

stories concerning HIV/AIDS and any celebrities reported-

ly dying from the disease. During this time I saw a per-

formance of ‘Torch Song Trilogy’ by Harvey Fierstein [2]

in a West End theatre. I remember I was incredibly moved

by this seminal production which allowed the public exam-

ination of how AIDS had affected the gay community dur-

ing the late seventies and early eighties in a more measured

and productive fashion. It had absolutely no scientific con-

tent but what it did for me was place HIV-1 into a human

context.

I know I am not alone in using personal accounts to help

work through medical writing tasks. Last year I was asked

to review oncology literature, a task I wanted to finish as

quickly as possible. Another writer also assigned to the job

approached the subject differently and began to read

‘Cancer: C: Because Cowards Get Cancer Too’ by John

Diamond [3]. The author had been a journalist in the UK

who recorded, in his newspaper column, his battle with

throat cancer. This book recounts his life, his cancer and all

the treatments he underwent and has very uplifting reviews

on Amazon.

In the UK in recent months there has been much discussion

around the outcome of the NICE review regarding avail-

ability of new dementia treatments. For those working in

this therapeutic area who want to find out more about what

this harrowing disease is like to live with on a day-to-day

basis, John Bayley’s memoir would be a good place to start

[4]. In this book he recounts the way normal life with his

wife of 45 years slips further, and further away from him

as the disease tightens its grip on her brain, ultimately

destroying her ability to function as a person.

Interested in the moral issues science throws at us? Why

not try reading the novel by Kazuo Ishiguro: ‘Never Let

Me Go’. This book will leave you thinking about the moral

dilemma of human cloning and all its implications [5].

Although not to be classed as a ‘light holiday read’ I

thought it was an exceptional book.

Reading round yourtherapeutic area



77

by Alison McIntosh



Reading round your therapeutic area

Where ‘reading round your therapeutic area’ is written from

a very personal perspective, Anne Hudson Jones has written

a series of academic articles on the contribution of literary

narrative to medical ethics. If you would like to examine the

moral and ethical issues this poses in greater detail then

accessing the articles would be a pertinent place to begin [6].

Perhaps you have used this ‘tactic’ in reading round your

therapeutic area? Do you have any recommendations? If so

please let us know. Maybe we could post them on the

EMWA website, or maybe we could start an EMWA ‘book

group’ with discussions at each of the Spring confer-

ences?….Or maybe I’m just a freelance medical writer

who needs to get out more!

Alison McIntoshAAG Medical WritingLoughborough, [email protected]

References:

1. Michael J. Fox. Lucky Man: A Memoir. 2003; Ebury Press; New Ed edition, UK.

2. Harvey Fierstein. Torch Song Trilogy. 1981; Gay Pr of New York, US.

3. John Diamond. C: Because Cowards Get Cancer Too. 1999; Vermilion; New

Ed edition, UK.

4. John Bayley. Iris: A Memoir of Iris Murdoch. 2002; Abacus; New Ed edition, UK.

5. Kazuo Ishiguro. Never Let Me Go. 2006. Faber and Faber; New Ed edition, UK.

6. A Hudson Jones. Narrative based medicine: narrative in medical ethics. BMJ.

1999 January 23; 318(7178): 253–256. (accessed 28 May 2007:

http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1114730).

The Lancet published a special issue entitled ‘Medicine

and Creativity’ in December 2006 (vol 328). This

included an excellent article by Anne Hudson Jones on

the beneficial effects of writing about illness (Jones AH.

Essay Writing and healing. Lancet 2006;368:S3-S4).

The article covers some of the well-established litera-

ture on patients’ narratives of illness and is a helpful

general reference to this literature.

Oxymoron The Merriam Webster on-line dictionary defines:-Oxymoron: plural oxymoraFunction: noun

Etymology: Late Greek oxymOron, from neuter ofoxymOros pointedly foolish, from Greek oxys sharp, keen+ mOros foolish: a combination of contradictory or incon-gruous words (as cruel kindness); broadly : something (asa concept) that is made up of contradictory or incongru-ous elements.

Roget’s Thesaurus does not list oxymoron in commonevery day usage. However, moron is listed as a personwith a learning disability. Very recently oxymoron seemsto have become an ‘in’ word. There was even discussionat the EMWA Spring conference about its meaning.Clearly some clarification is called for. Paul Dunne([email protected]) researched the word and found the daily

usage of the term oxymoron may refer to a person who, intrying to be clever, may end up appearing foolish in thepresence of their peers. He found no reference to this pos-sibility in a present day dictionary or other references. Onasking people about their experiences with the word Paulcollected the following examples:

wise fool warm freezer legal murderplastic glass adult children good morningpretty ugly questionable answer alone togetherdangerously safe fun run civil war

With all deliberate speed (go quickly, slowly) Festina lente (Latin), hasten slowly

‘So foul and fair a day, I have not yet seen.’ (Shakespeare, Macbeth, Act I, Scene III).

Oxymoron is quite often used in jokes, e.g. ‘military intel-ligence’: intelligence (1) meaning intellect or use of brain,and (2) knowledge about enemy country. Another oxy-moron joke might be ‘honest politician’, which impliesthere are no honest politicians!

In the last issue of The Write Stuff (TWS), you heard about

my journey to freelance medical writing and my first three

months in business. The next three have been no less inter-

esting, with new challenges presenting themselves, some-

times on a daily basis! I have gained new clients, and diver-

sified my portfolio to take on training roles within my local

university. Read on for an insight into the highs and lows I

have experienced during my second quarter in business.

Months 3 to 6January 2007The seasonal holidays were well and truly over with the

children back at school and the decorations boxed up in the

loft. I was eager to pick up on two projects where I left

them in late December 2006. I was expecting final statisti-

cal output for one study, enabling me to begin draft report-

ing, and I was to begin front-ending another report. January

looked set to be a busy month, or so I thought… A couple

of days after I received efficacy output for the draft report,

it became clear from ensuing discussion that the safety out-

put ‘was not quite ready yet’.

There were also some issues

with the efficacy data which

would require further statisti-

cal review, however, the

required resource would sim-

ply not be available for what could be several weeks and

possibly a few months. As for the front-end report I was

supposed to be preparing, that completely disappeared into

the ether. Suddenly, my packed January was looking a lit-

tle freer.

I took advantage of the immediate gap in my writing for-

tunes by embarking on the new year exercise plan I had

vaguely considered over the holidays. Exercise is great for

allowing space and time to think. Having recognised that

the reality of unmet milestones meant payment delays,

sometimes long ones, I made a mental note to build in an

extra assumption for milestone contract bids. I would

reduce my risk by stating that I would invoice for the work

done to date where milestones were delayed by the client,

and deduct that amount from the eventual milestone pay-

ment. I also saw that I was going to need several more con-

tracts ongoing simultaneously to absorb potential delays

and apparently contracted work.

The rest of January 2007 was therefore spent on intensive

business development activities. I went back to square one

and trawled the internet, applied for several contract posi-

tions of interest via InPharm.com and got back in touch

with old contacts to ask if they were in need of writing

services. I re-examined some of the e-mail applications I

had sent out before the holidays. I restructured them by

comprehensively stating my experience and capabilities in

the covering e-mail, rather than relying on the reader to

actually make it to my web link and CV to review this key

information. It was a simple enough presentational change,

but amazingly, it appeared to do the trick. Within a few

hours, requests for information and invitations to bid for

projects started to appear in my in-box. I had learnt the

valuable lesson of gaining the attention of potential clients

within the first few lines of an e-mail.

I was delighted to be invited by Alistair Reeves, EMWA

Freelance Coordinator, to help out with the set up, conduct

and reporting of the Freelance and Small Business Survey

planned for 2007.

February 2007I updated the material for my website and had a few infor-mation technology glitches I was experiencing, ironed out.With ongoing business development activities, but no bill-able work as yet, it seemed like a good time to get away fora few days to celebrate our 15th wedding anniversary. Withthe children’s Gran installed at home, Paul and I escaped toKrakow, Poland, for what was an impromptu break in acultured jewel of a city. Paul reminded me that had I stillbeen a paid company employee, I would never have had therequisite annual leave in hand to make this trip.

My return to work heraldedthe beginning of an absoluteonslaught of enquiries, andmore importantly, contractwins. I sent out a total ofeleven requests for informa-tion and bids in as manydays. I had also been concen-trating on developing longerterm relationships with somecompanies, so that the work

would not completely dry up once I had closed out individ-ual project contracts. That strategy was paying dividends. Isigned three separate contracts for periods of 6 to 12months to provide medical writing services, on an ‘as-needed’ basis. I also won several individual pieces of work,not all associated with the 6 to 12 month contracts. Threeof these clients were hoping to use my first piece of workto decide if they wanted to develop a longer term relation-

A personal account of myfirst year as a freelancemedical writer



79

By Samina Hamilton

January looked setto be a busy month,

or so I thought…

I had learnt thevaluable lesson ofgaining theattention ofpotential clientswithin the first fewlines of an e-mail.



A personal account of my first year as a freelance medical writer

ship with me. For the first time since starting out on myown, I had what I considered to be a healthy backlog ofwork that would occupy me until the end of June 2007. Ihad breathing space in early July before our scheduledfamily holiday in late July/early August, and I was in dis-cussion with two clients about work for my return fromholiday.

Another interesting opportunity arose during February

which really caught my imagination. My good friend,

Helen, with whom I had done my PhD, had called me to

discuss ‘something big’. We had both ended up as free-

lance medical writers and she now lived with her American

husband and two children in

the US. We had stayed in

touch over the years and

were now enjoying more reg-

ular contact, mainly because

our working lives now

allowed it. Helen had been

invited to bid for a very large

contract with a major phar-

maceutical company. It was

for a programme of early

phase protocols and there

were enough of them to keep several writers busy for a

period of 18-24 months. She asked for my counsel during

the bidding process and for me to be part of her team,

should she secure a win. I was delighted to be included and

we had fun working together on her bid. I spoke with sev-

eral UK-based freelancers to ensure that I would be able to

resource the UK end of the operation in the event of a win.

With the bid safely with the client, Helen and I both put it

to the back of our minds. So far, we have been lucky

enough to be able to subcontract small pieces of work to

one another from time to time, and we both hope to nurture

this working relationship as our businesses develop.

March 2007At the EMWA Brussels conference, I had realised from

talking to experienced freelancers, that it would be perti-

nent to contact my local university and hospitals trust, as

this could unearth potential business from an alternative

sector. I decided to try a multi-pronged approach to make

the quickest possible in-roads. I approached parents at my

children’s school whom I knew were hospital consultants

associated with groups involved in clinical research. I also

joined the Healthcare Network North East England

(www.hcnetnee.com), a local organisation which works

with companies, including those involved in clinical

research, to increase sales and market opportunity through

networking. Both approaches initially drew a blank. It then

occurred to me that I should make the best of existing,

albeit dormant, contacts. My next, and best move so far,

was to contact my old PhD supervisor, who was now not

without professorial clout, and was still based at the

University of Newcastle Upon Tyne. I updated him on the

last 15 years of my life and then asked him to spread the

word about my services at the university and within the

hospitals trust. He very kindly facilitated some key intro-

ductions for me and I soon had enquiries and two contracts

in process from a newly formed hospital-based group over-

seeing the conduct of clinical trials in the region. Great! I

had broken into the local market, and my breathing space

in early July started to shrink. It was rather fun to be going

out and meeting local researchers, not to mention revisiting

the medical school where I had studied and worked for so

many years. Oh, did I forget to mention that I agreed to

present a postgraduate training seminar in July 2007 to talk

about my career to date, and the possibilities for careers in

clinical research? I’m not sure the promise of a buffet

lunch and university car parking permit for the day sold it

to me though; I think it was more the opportunity to show

that a fulfilling career, via the path I had chosen, can be a

viable and achievable alternative to a career in academia.

Alistair and I were in touch over the survey and

Freelancers’ Forum planned for the Vienna conference. I

registered for EMWA Vienna, or rather two days of the

whole, as the conference was unfortunately scheduled right

in the middle of my reporting two studies.

I was writing again too, to my relief. I began reporting for

two new clients, in addition to updating the report which

had stalled in January. I also

won three unexpected, small-

er pieces of work which I

wrote and closed out during

the month.

Late March was a very busy

period for me, as I hit critical

path on a large clinical study

report. I luckily remembered

to submit my second value

added tax (VAT) return just in the nick of time. Never a dull

moment… I now look forward to a slight breather over the

Easter holidays (or at least part of them) with the family.

I will continue to update you as I navigate my way through

my first year in business, so look out for my articles in

future issues of TWS.

Samina Hamilton Sam Hamilton Medical Writing Services LimitedNewcastle Upon Tyne, [email protected]

…had I still been apaid company

employee, I wouldnever have had the

requisite annualleave in hand to

make this trip.

I luckilyremembered that mysecond value addedtax (VAT) returnwas due just in thenick of time…

Internet healthcare Rumour has it healthcare is the most searched topic on

the Internet. MedHunters.com1 tells us that searching

healthcare is more popular with teenagers than online

games. The site outlines how to find healthcare informa-

tion on the Internet and lists some useful sources.

1. www.medhunters.com/articles/healthcareOnTheInternet.html



81

Reflections on jargon

Dear TWSAs past issues, the December 2006 issue of TWS has a

very engaging mix of items—instructive, provoking

thought and discourse, and humorous. For me, your brief

on jargon (page 137) created the critical mass that would

overcome my reticence and unleash an outpouring of

resentment and opinion on the use of jargon. I’d like to

share them with you. But first, a couple of comments:

1. Jargon is not limited to American businesses. In fact,

American bureaucratized bodies (especially govern-

mental ones) and entities that have hierarchic struc-

tures, accountability, and spheres of influence are

hotbeds of jargon. In my work I frequently come

across jargon also in the initial, unedited drafts of

medical articles from both English and non-English

speaking countries, or in the published copy of less

rigorously edited clinical journals; and I am puzzled

and irritated by their authors’ ritualistic and

unabashed use of tumescent single words, disorderly

telegraphic contractions, or pompous phrases—which

seem like cars that are designed to look deceptively

substantial, but which are dressed with frangible sheet

metal around weak engines and unsteady mechanisms.

2. Single- or multi-word jargon takes a variety of forms.

The speeches of lay circles—in-speak, slang, collo-

quialism, clichés, youth-speak, rap-speak, hip-

speak—are full of the plebeian relatives of profes-

sional jargon. Euphemisms, clichés and the like are

not too distant. The examples of jargon you gave in

TWS are mainly buzzwords—contrived and after the

limelight but practical for economically conveying

broad and complex concepts.

Listed below randomly are some very subjective thoughts

I have had over recent years on why jargon thrives though

simpler language is preferable. They are conjectural; and

perhaps combined linguistic, sociological and psycholog-

ical studies might debunk my suspicions—or on the other

hand, elevate their stature.

• Jargon is a stand-in for passwords for admission and

verification of belonging to fraternities or regiments.

It substitutes for some rites of initiation and recita-

tions of pledges of allegiance.

• It is the verbal vestment of ritual. Its use has liturgical

quality and is the invocation for pomp (therefore

“pompous” language). At times it is no more than

mantra, its effect not much different from the touch

that spins prayer wheels.

• The user of jargon is kowtowing verbally, is validat-

ing the reverence-worthiness of a hierarchy and the

office at its summit, and consciously or unconscious-

ly, but oftentimes imitatively, is striving to demon-

strate to others, and simultaneously confirm to one-

self, arrival, belonging, fealty, and obedience, and

subservience in one direction and rank in the other.• Given the opacity of content that it masks, the delib-

erate use of jargon cannot but be accompanied bysome conscious compromise of the self. Its uncon-scious use implies another type of intellectual deficit.

• It is possible that because American society and cul-ture have not had a history of monarchy and elitism(the latter is not all that unrelated to the former), andbecause, most would agree, the level of education andliteracy that most American schools provide is gener-ally weak, jargon thrives because it has survivalvalue. It helps cover up faults in its user’s thoughtprocesses. It supports pretensions of being hip, savvyand branchée. It helps create illusions of the conse-quentiality, inaccessibility, and indispensability that apseudo-expert or an arriviste “authority” strives for.Perhaps the use of jargon in America is a sublimationof unspoken attractions to elitism and virtual royalty.

• Despite the preceding, organizational or professionaljargon might be seen also as a tool that, on a verysubliminal level, helps distance the arena where jar-gon is used from the user’s personal/“private” life.Jargon may be a way of asserting individual independ-ence and maintaining separation between work andobligation, on one hand, and the self, on the other.

• Why do the French, chauvinistic and resistant to theadulteration of their language and culture, accept theuse of foreign words (especially English ones) in theirday-to-day affairs? One possibility is that they usethose words as jargon—to capitalize on the easy han-dle that the alien words provide of alien concepts, butat the same time to impede the full integration of theconcepts themselves into conservative French hearthsand life. In other words, if it is foreign keep it foreign.

• In oral communication, simple words or phrasescould be articulated in ways to make them sound asjargon. If one were to spend a little time observingsome prominent contemporary politicians one couldconclude that the most simpleminded of them have theinborn talent to make jargon out of 8-graders’ language.

Having risked being accused of jargon-mongering myself,I finish with an open message, cast out in the bottle of TWS,to all aspiring medical authors out there: it takes resolveand effort (and sometimes the intervention of an editor) tocheck the urge to imitatively use jargon based on theassumption that it is expected of you and you need it forprofessional acceptance. And if you’re resorting to stiltedlanguage to mask weaknesses in arguments or of trivialinformation in search of publication, shame on you all!

Jack AslanianOakland, California, [email protected]



Eureka!When you find a good solution for expressing a particu-

lar idea after searching for years, you feel like

Archimedes jumping out of the bath! This may not have

the same repercussions as the testing of Hiero’s crown,

but I have finally found a reasonable way of solving the

problem described below.

In German, and I suspect other related languages, it is

quite acceptable to write the following, for example, as

a withdrawal criterion: If patients require treatment withan NSAID, especially aspirin, they must be withdrawn.German-speaking authors writing in English also often

use this type of formulation, which is nonsense in

English. ‘Especially’ and ‘in particular’ (and similar

terms) are the problem: directly from ‘insbesondere’ in

German. Does this mean that there may be less of a rea-

son to withdraw a patient treated with the NSAID

ibuprofen? Certainly not because the exclusion criterion

states that patients treated with NSAIDs must be with-

drawn. Discussions with authors over the years have

revealed that this formulation is used when they want to

give an example of what may frequently happen: in this

case, aspirin, as a very commonly prescribed NSAID, is

particularly likely to be prescribed, but no treatment

with any NSAID is allowed.

We have to accept that this does not appear to be objec-

tionable to German speakers, but it clearly doesn’t work

in English, so we have to find a passable solution. The

solution I have recently come across is to say in such

cases: Patients requiring treatment with aspirin or otherNSAIDs must be withdrawn. Not literally what the

German says, but it conveys exactly the same idea. (The

astute reader will still wonder why the author didn’t sim-

ply say: Patients requiring treatment with NSAIDS mustbe withdrawn, but let’s not get picky.)

A further possibility is to say: Patients requiring treat-ment with NSAIDs, for example aspirin, must be with-drawn. But this solution sounds strange in the following

situation (as an exclusion criterion): Patients with a his-tory of circulatory disorders, for example peripheralvascular disease, are not eligible. Here ‘Patients with ahistory of peripheral vascular disease or other circula-tory disorders are not eligible’ is definitely preferable.


Mixed metaphorsHaving been asked to edit a short document on the pre-

vention of hepatitis B I was astounded by the metaphors

in the short passage that follows:

“Thirty years ago, the outlook for the prevention of hep-

atitis B looked bleak.a However, the adventb of hepatitis

B vaccines provided hope throughout the worldc that this

disease would one day be conquered. Since that time,

great strides have been made in preventing the spread of

hepatitis B. We still have a long way to go before this

disease can be confined to the history books, but the

future looks bright!d”

aI’m not sure if an outlook can look bleak. Alternatively,

perhaps hepatitis B itself has an outlook, in which case

these viruses are a lot cleverer than I realised.

bAdvent always makes me think of Christmas.

cAre we back in Christ’s birthday territory? Can be real-

ly rule out that hepatitis B vaccines would not provide

hope in a galaxy far, far away?

dThough not the author.

I felt physically ill after reading this, with the final excla-

mation mark the (metaphorical) dagger in my guts. Bear in

mind that this was written by a medical writer with years

of experience in medical writing, so there are no mitigat-

ing circumstances (Mixed metaphor disease must be con-

tagious as now I’m starting to write in that style too.)

Richard [email protected]

Why –ing forms can beconfusing, and the power ofhyphenation Version 1: These molecules are designed to resist proteinbinding and would be interspersed with the specific pro-tein binding molecules of the protein array (e.g., anti-bodies, fusion proteins, etc.).

Does the protein bind molecules of the protein array, or

do the molecules bind the protein?

Version 2: These molecules are designed to resist pro-tein binding and would be interspersed with the specificprotein–binding molecules of the protein array (e.g.,antibodies, fusion proteins, etc.).

Now we know that it’s the molecules which bind specific

proteins.

Karen [email protected]

Lost Property OfficeWhat will be the European Union’s standard for a ‘lost

property office’ which in French, German and Polish trans-

lates as a ‘found property office’? Only found property is

in the office but people who have lost property come to

claim it.



Here are 5 more myths about English (if you would like to

know why I wrote '5' here and not 'five', see Myth 1 [1]).

Myth 16: ‘Localisation’ is more precisethan ‘site’It is not. At first sight, the simplest and best reason to pre-

fer ‘site’ over ‘localisation’ is that it has only 1 syllable and

not 5, and does not put you in the quandary of wondering

whether it should be written with an ‘s’ or a ‘z’ (see Myth

5 [2]). But there is an even better reason not to use ‘locali-

sation’ when you mean the place on the body where a

patient developed a rash: quite simply, it is wrong, anddoes not mean ‘site’. ‘To localise’ means ‘to restrict or

assign to a particular place’ (hence ‘local’ anaesthetic), ‘to

invest with the characteristics of a particular place’ or ‘to

decentralise’ something [4]. ‘Localisation’ (noun) is

derived from ‘localise’, and it is the activity of localising,

and only that.

Etymologically close relatives of ‘to localise’ are ‘to

locate’ and ‘location’: ‘to locate’ is ‘to discover the place of

something’ or ‘to put something in a particular place’ [4].

‘Location’ means where something is or happens, and is

therefore a possible substitute for ‘site’; but because mono-

syllabic ‘site’ is just as good, it should be given preference.

‘Location’ also means the act of locating (like ‘finding’),

and does have other meanings too, e.g. ‘a film location’. If

you can’t quite manage to make the transition to ‘site’,

‘body site’ is fine too.

Myth 17: ‘Contralateral’ is a useful word inour contextIn most cases, plain old ‘other’ or the opposite of ‘left’ or

‘right’ does a better job, because everyone understands

these, and they are much shorter. Contralateral (the one on

the other side), and the rarer ipsilateral (the one on the side

you are not talking about when you refer to the other side),

are used for body parts that occur in pairs on either side of

the body—and there are quite a few such parts. Examples

of the use of ‘contralateral’: ‘If blood samples are takenfrom the right arm, the blood pressure should be measuredon the contralateral arm’ or ‘The contralateral breastshould also be closely inspected for changes’. But why

bother with such a mouthful, even if it sounds good? ‘Left’

would have been just as good in the first instance, and

‘other’ in the second. Still worse is the ‘contralateral side

of the body’—a tautology, because ‘lateral’ already

includes the concept of ‘side’. It is often astonishing how

writers will leap to use a complex word in written scientif-

ic texts when a simple one will do: after all, if you came

into a room with two doors, one on either side, would you

ever write: ‘I came in through that door and she came inthrough the contralateral door’?

The use of contralateral is justified in the following and sim-

ilar instances (title of a journal article): Are men with testic-ular cancer at risk of developing a contralateral tumour?

Myth 18: ‘Post’ is acceptable as apreposition in our contextI thank Chris Priestley of Accovion GmbH, Eschborn,

Germany for drawing my attention to this one.

Using ‘post’ as a preposition in the following way is jar-

gon, and should be reserved for speaking or medical notes:

• Post dosing, the animals showed …

• Post hysterectomy, the patient had …

• Patients should be mobilised within 24 hours post sur-

gery

• Post end of treatment, 7 patients reported …

• Post mixing, the malleable mass is transferred to a

450 L bowl.

We all know that post means ‘after’ and that the above

examples will never be misunderstood, but ‘after’ is the

preferable solution for all similar constructions in written

English (‘After the…’ in number fourth). Watch out for the

use of ‘following’: see Myth 9 [2]. In all the above cases,

‘post’ would never be hyphenated—and this is perhaps a

good indicator of whether you can use it or not in formal

writing: if you are not tempted to hyphenate it (i.e. are not

using it as a prefix but a preposition), you will usually be

able to substitute ‘after’. ‘Post’ has not yet entered the

realms of written prepositional use, but is used as a prefix

indicating ‘after’ or ‘behind’. Well-accepted examples are

(hyphenation is up to you; I usually write them as one

word): posttreatment, postinfusion, postpartum, postpran-

dial(ly), postpubertal(ly), postnatal(ly), and anatomical

terms such as postnasal(ly), postsplenic and postganglion-

ic. Many instances where ‘post’ is used as a prefix cannot

be found in medical dictionaries. Formulations like ‘The

patient had post-dialysis concentrations of …’ have been

taking hold for years now, and it is beginning to sound

pedantic to insist on: ‘After dialysis, the concentrations of

…’. But: ‘It is important to measure the blood pressure

post dialysis’ is still not acceptable.

5 more myths about English (4)by Alistair Reeves

> > >



85

More myths about English> > >

Myth 19: ‘and/or’ has to be used to allowfor all possibilitiesDescribed very fittingly by Anne Jones [5] as a ‘term of

unfathomable meaning’, ‘and/or’ is always difficult to jus-

tify, and it is better to avoid it altogether.

The ‘and’ is almost always superfluous. This is one

instance in English where native speakers have it easier:

because we spontaneously just say and write only ‘or’, and

this is almost always all that is needed (listen out for

‘and/or’ in conversation—you will hardly ever hear it).

Many non-native speakers of English cannot render this

with plain old ‘or’ in their own language (because ‘or’ is

used ‘exclusively’ [see below], or they have other words),

and this makes it difficult for them to cross the threshold of

just using ‘or’ in English.

Consider the following: ‘If the patient develops vomitingor dizziness, the infusion will be stopped immediately’.

Which brute is going to leave this poor woman on the infu-

sion if she develops vomiting and dizziness?

And the following: ‘Space should be provided for the studyparticipant and/or investigator to make notes.’ (in the

instructions on the preparation of an informed consent

form).

What does this actually mean? It means that we should

allow for the following possibilities:

• The investigator might want to make notes, and we

should provide white space entitled ‘Investigator notes’.

• The study participant might want to make notes, and we

should provide white space entitled ‘Study participant

notes’.

It is highly unlikely that we wish to provide for the ridicu-

lous situation that the study participant and the investigator

will actually want to hold the same pen and write the same

note together on an area of white space entitled

‘Investigator and study participant notes’. The ‘and’ is

therefore superfluous, and ‘Space should be provided forthe study participant or investigator to make notes’ is quite

adequate.

Another example (from an SOP): As sponsor of a clinicaltrial, the University has the overall responsibility for thetrial and may use the services of third parties (such aspharmaceutical companies, associations, foundations, andothers), e.g. for the supply of trial medication and/or finan-cial support.

A daft ‘and/or’, if ever I saw one. Why? First, there is an

‘e.g.’, so you’re giving examples and there could be count-

less other ‘ands’ and ‘ors’. Second, why allow for the pos-

sibility that you may have only the trial medication from

one source, only the financial support from a different

source, or both from the same source (if this what the ‘and’

is supposed to mean here—probably not, I think it’s just

sloppy and ‘overprecise’ use)1. Third, even if you just said

‘or’, it is so obviously not exclusive here, and clearly does

not mean that the sponsor has to chose between either trial

medication or financial support, or that there would be

problems if the source of both were the same.

Finally, the daftest of all, which I leave without comment:

Narratives are provided for all patients who died on studytreatment and/or within 30 days of the last dose of studymedication.

Dispensing with ‘and’ and just using ‘or’ is called using the

‘inclusive or’, and obviates the use of ‘and/or’ completely.

Most misused ‘and/ors’ fall into this category.

Why do so many native speakers use ‘and/or’ then, when

writing, if we spontaneously use just ‘or’? I surmise that it

is because they think it sounds more precise and have so

often been bullied into writing this by pernickety col-

leagues from the ‘Ah-yes-but-what-if’-school that they

feel the ‘and’ makes things clearer or ‘covers everything’.

But it does not.

If the exclusivity of ‘or’ is important, it is either obvious

from the context: ‘You can pay for lunch or dinner’—faced

with this choice, who would pay ‘inclusively’ for both? Or

there are linguistic devices available. This is why we have

‘either’ and ‘or’: ‘If patients develop headache, they maybe treated with either paracetamol or ibuprofen’. Whilst it

would be impossible to prevent a patient being treated with

both, implicit here is that a choice has to be made. If the

converse is the case and combination treatment is allowed,

you can always add ‘or both’: ‘If patients developheadache, they may be treated with paracetamol or ibupro-fen, or both.’ To add an ‘either’ before the ‘paracetamol’ in

this case would not be wrong, but is unnecessary. This, of

course, means the same as: ‘If patients develop headache,they may be treated with paracetamol and/or ibuprofen’,and is one instance where some may try to argue for

‘and/or’. Not me: I still prefer the ‘or both’ solution,

because the reader does not have to backtrack: I bet most

people reading ‘and/or’ backtrack a little to be sure that

they have understood the sentence properly: to make read-

ers backtrack is to be unkind to them.

Is trying to avoid ‘and/or’ a lost cause? I hope not.

This use of ‘and/or’ also calls into question the use of the

‘slash’ in general, and its almost always ambiguous use. It

is worth reading Stephen de Looze’s TWS article on this;

Ann Jones also discusses this point [5, 6].

1 The sloppiness and inconsistency of this text—although in an SOP—is shown by the author’s failing to use ‘and/or’ in the brackets before ‘others’ because it was felt neces-

sary in exactly the same situation in the next clause. ‘Others’ is superfluous, anyway, because of the ‘such as’, and this only makes it worse.



More myths about English

Myth 20: The correct abbreviation for litreis now ‘L’Thanks to Anne Bartz, freelance translator and medical

writer, Hamburg, Germany for telling me that she recently

heard this was now a ‘rule’ in British usage and asking

whether this is a myth, although not specifically a myth

about English.

It may surprise you to read this (I was surprised, anyway),

but litre is not an official Système International d’Unités

unit [7]. This means there is no ‘official’ abbreviation for

‘litre’, so we can do what we want (Oh dear! No rule

again!). There has been a trend towards writing ‘L’ for litre

for a few years now, I suspect because of the possibility of

confusion between ‘1’ and ‘l’, and this is probably due to

all the fonts we have in word processing (i.e. the distinction

used to be clear with the typewriter). The difference is

obvious with ‘sans serif fonts’—Arial: ‘l’ or ‘1’—but not

so obvious with ‘serif’ fonts (i.e. Times [Roman]-like

fonts)—Times New Roman: ‘l’ or ‘1’. Sometime someone

probably started using ‘L’ and it has gradually caught on. I

responded to the trend and often now use ‘L’. Message as

usual: be consistent in one text.

Note on Myth 11: No comma after ‘e.g.’and ‘i.e.’:I thank Diana Taylor, Parexel International, Berlin, Germany

for supporting me in spurning the use of the comma after

‘i.e.’ and ‘e.g.’ [3]. Diana pointed out that this is also support-

ed by Fowler’s Modern English Usage [8], except for the fol-

lowing situation: ‘He attacked reactionaries, i.e., it would

seem, those who opinions [etc.]…’. I am pleased to hear this,

as I do not frequently consult Fowler (perhaps I should), but

had I consulted Fowler on this one, this example would not

have increased by readiness to revise my opinion.

Alistair ReevesAscribe Medical Writing and Translation, Wiesbaden, [email protected]://www.ascribe.de

References:

1. Reeves A. Myths about English TWS 2006;15(1):22

2. Reeves A. More Myths about English TWS 2006;15(2):58

3. Reeves A. More Myths about English (3) TWS 2006;15(4):139

4. Oxford English Reference Dictionary. OUP. 1996

5. Jones A. Ever-changing English. A translator’s headache http://www.transla-

tiondirectory.com/article1060.htm

6. de Looze S. Slash the Slash TWS 2001;10(4):89-93

(http://www.emwa.org/Articles/Slash.pdf)

7. http://www.physics.nist.gov/cuu/Units/

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In the Bookstores...

A Call to Make PatientsEffective Partners in MedicalResearch Imogen Evans, Hazel Thornton, Iain Chalmers. TestingTreatments. Better Research for Better Healthcare. London:The British Library, 2006. ISBN 0-7123-4909-X(Paperback). GBP 12.95, EUR approx. 19.00. 116 pages.

This book can be highly recom-

mended to general practitioners

and users of healthcare services

(all of us!), because it is enlighten-

ing about how clinical trials are

designed, how their results are

analysed and communicated, and

how biases in the creation of new

medical knowledge can influence

treatment decisions, and thus the

quality of healthcare. By targeting

the book to both healthcare users and healthcare providers,

the authors hope to teach both how to tell the difference

between biased and trustworthy information, so that they

can more confidently judge the reliability of data, research

reports, advertisements, and other sources of information.

In clear, sensible prose (a credit to the authors’ writing

skills and to the adroit copyeditor), the three authors show

“how the existing ‘drivers’ for research—commercial and

academic—have not done enough to identify patients’ pri-

orities” (p. 96). Their goal is to convince readers that “bet-

ter testing of treatments in the future should come from

productive partnership between researchers and patients”

(p. 80). The topics chosen for inclusion, the straightfor-

wardness of the authors’ reasoning, and the evidence from

medical journals, the lay press, and patient-advocacy

groups, make for a convincing read. The information

sources are rigourous, and the information itself, some of

which involves complex concepts related to research study

design and methods, is explained in a way that is not at all

condescending, but rather encourages readers to learn

more. The authors’ successful transfer to a wider audience

of information usually intended for specialists in biomed-

ical and pharmaceutical research is a lesson for writers and

editors who aspire to publish effective consumer outreach

and education materials.

The book starts with an Acknowledgements section, a

Foreword and an Introduction, which are followed by eight

chapters that identify specific shortcomings in current

medical research, explain why these problems make the

research less useful than it could be, and suggest ways in

which the problems could be overcome. At the back of the

book are an up-to-date reference list, a brief list of addi-

tional resources (some of which are worth investigating for

medical writers, translators and editors), and an index.

Chapter 1 explains why “too much medical decision-mak-



87

ing is based on poor evidence” (p. 2)—a claim that might

surprise readers who assume that all researchers, medical

affairs managers, journal editors, and government agencies

know what they’re doing. In subsequent chapters the

authors explain the basic principles of testing treatments,

and tell readers how reliable evidence of treatment effects

can be obtained. Chapter 2 lays out the dangers of using

treatments that, despite their widespread acceptance by

healthcare professionals and patients, are not based on

sound evidence. The authors then explain how “fair” (i.e.,

unbiased) experimental or comparative studies should be

designed (Chapter 3), and lift the veil on clinical trials by

explaining the ideal methodological characteristics of this

“gold standard”. The examples of how blinding, double-

blinding, and randomization are used to overcome potential

sources of bias in study design and interpretation are espe-

cially helpful. In Chapter 4, strategies that clinicians,

patients and researchers can use to reduce uncertainty in

making treatment decisions are described, and consumers

are encouraged to participate more actively in treatment

decisions. Problems that can compromise the trustworthi-

ness of the results of clinical trials are analysed in Chapters

5 and 6.

Especially instructive is the authors’ explanation of how

the choice of research topics is influenced by pharmaceuti-

cal firms’ commercial interests and researchers’ need to

obtain professional recognition—two powerful socioeco-

nomic factors that can prevent certain health problems

from receiving the attention they deserve. The book con-

cludes (Chapter 7) with a strong plea for patients to organ-

ize and become more actively involved in setting the med-

ical research agenda. The authors then give us a seven-

point “blueprint for a revolution” (Chapter 8), and an

action plan for users of healthcare services who wish to

become better informed about the quality of care and of the

evidence it is based on.

The text itself is highly readable, and the way the book is

organized into short chapters is also reader-friendly. The

layout was probably chosen on the assumption that reading

will be frequently interrupted (as is likely for most general

practitioners and other busy people), so readers can come

back to the text later without losing the thread. Boxed

quotes provide referenced examples and supporting mate-

rial for readers with a bit more time, and each chapter ends

with a short list of key points that summarize the main

messages.

To help improve the quality of medical research, the

authors advocate active participation by patients and user

groups in designing research and evaluating the evidence,

and recommend that clinicians and patients improve their

ability to critically evaluate research to detect biases and



In the Bookstores...

inaccuracies. In addition to its didactic value as an intro-

duction to biomedical research methods, the book contains

both an effective consumer-enabling message and impor-

tant insights (for clinicians as well as patients) into how

research can fail to meet the goal of providing better

healthcare. This short, educational book encourages users

and providers of healthcare to question assumptions, detect

biases, raise questions about the quality of the evidence if

they find it unconvincing, and work together to ensure that

the right research questions are asked, and the right

research is used to find the answers.

Can You Trust What You Readin Medical Journals? Richard Smith. The Trouble with Medical Journals.London: The Royal Society of Medicine Press, Ltd., 2006.ISBN 1-85315-673-6 (Paperback). GBP 19.95, EURapprox. 29.25. 292 pages.

As editor of the BMJ from 1991 to

2004, Smith witnessed many

types of misconduct and question-

able practice by researchers,

reviewers, editors, clinical trial

sponsors, and medical journal

publishers, and he remains at the

forefront of efforts to profession-

alize medical journal editing. In

this book the author describes

some of the challenges the BMJfaced during his tenure as editor, examines how other jour-

nals have dealt with their own challenges, and explains

why the trouble with medical journals should matter to

everyone. He melds his first-hand experiences with a non-

systematic but wide-ranging review of the editology litera-

ture pertaining to biomedical journals, and the result is a

spicy story of the factors that conspire to make journals

less effective, less reliable, and less accountable for their

errors than Smith, for all his pungent criticisms, passion-

ately wishes they could be.

The contents are divided into seven sections comprising

one to five chapters each, with no illustrations or tables.

Section 1 consists of a single chapter titled ‘Introduction:

medical journals are probably a force for good but need

considerable reform’. This statement is supported by evi-

dence presented in the subsequent six sections, ‘The nature

of medical journals’, ‘The processes of publishing medical

research’, ‘Problems in publishing medical research’,

‘Important relationships of medical journals’, ‘Ethical

accountability of researchers and journals’, and ‘The

future’. A total of 418 references are cited; it would have

been helpful to place them at the end of each chapter rather

than list them all at the end of the book, where they are

harder to check as one reads (especially as no headings

were used to identify which chapter the references belong

to). The index at the back of the book is helpful but not as

thorough as it might have been given the very large range

of topics mentioned; some cross-references and pages on

which entries and subentries are mentioned seem to have

been missed. But interested readers will nonetheless find

much to make the book worth reading cover to cover.

Smith gives us the human side of journal editing, and

emphasizes that problems with journals are unavoidable

because many of the decisions that reviewers and editors

make are based as much on judgement and opinion as on

fact. Sources of pressure and conflicts of interest that can

bias decisions about what to publish are also identified and

discussed with reference to cases in the BMJ and else-

where. The mixture of case histories of editorial mishaps

and Smith’s analysis of their implications for the trustwor-

thiness of journals makes the book a valuable educational

resource for editors and reviewers, and a gold mine of data

for journalologists.

The author is careful to point out that the BMJ and TheLancet (mentioned several times for purposes of compari-

son) are not typical medical journals, because their editors

were (or are, in the case of Richard Horton, Editor-in-Chief

of The Lancet) unafraid to publish provocative articles, try

innovative editorial policies, and embroil their journals in

controversy. These journals are well-off financially and

highly respected, and so can afford to be bolder than most

others, whose editors may consider discretion, rather than

risk-taking, as the better part of valour. Both of the UK’s top

general medical journals have enjoyed huge successes and

survived painful mistakes, but as Smith has declared more

than once with regard to the journal he edited, “the BMJ is

not in the truth business but the debate business” (p. 30).

A couple of chapters are not directly relevant to Smith’s

analysis of the trouble with medical journals, and the writ-

ing is, in a few places, so impetuous that passion has over-

ridden clarity. The rather critical review of the book that

was published in the BMJ [1] took issue with Smith’s

views on specific issues, while overlooking the book’s

timeliness and usefulness. Smith is indeed opinionated, but

is nonetheless one of the world’s experts in peer review and

good professional practice for editors. Even if your job does

not involve gatekeeping responsibilities, his analysis and

opinions are worth reading as a record of how well medical

journals are performing now that the media, the public, and

regulatory institutions have become aware of the abuses that

can undermine their reliability as sources of information.

So, can you trust what you read in medical journals? The

author would answer, “Sometimes, but not always”.

Journals document advances in basic and clinical research,

and perform the necessary roles of screening information,

improving how the research is reported, and disseminating

the results. As filters, journals are not one hundred percent

accurate at distinguishing between good and bad research;

as a manuscript review and editing service, peer review is > > >



89

In the Bookstores...> > >

only partly effective in improving how accurately and

transparently the research is reported; as information trans-

fer tools, journals are not always published in ways that

facilitate access to the information in resource-challenged

settings. To make journals more useful sources of informa-

tion, editors and reviewers need more support in learning

how to make their journals better. Smith’s book helps by

educating gatekeepers, researchers, health care users, and

ethics experts alike about the limitations of medical jour-

nals. In showing which processes are most vulnerable to

abuse or incompetence, the author has done all users of

medical journals a huge favour by suggesting how to avoid

many of the pitfalls that arise from the human efforts need-

ed to publish them.

References:

1. Derbyshire SWG. Medical journals: past their sell by date? BMJ 2007; 334

(6 January): 45

Medical Writing for ManagersDiana A. Taylor. Healthywords. Towards a Betterment inMedical Communications Across the Drug Industry. AnOperational Handbook for Managers. Alan Taylor, ed.Marburg: Tectum, 2006. ISBN 3-8288-9083-0 (Paperback).EUR 24.90. 187 pages.

Taylor has made a career of advis-

ing medical information and med-

ical affairs (MI/MA) managers on

how to develop their staff’s col-

laborative writing skills and use

them effectively to support phar-

maceutical firms’ goals. In this

book the author has set herself the

ambitious task of using research in

text readability and her knowledge

of current European regulations

aimed at protecting patients’ rights to explain why MI/MA

managers need to develop medical writing teams that func-

tion as a “knowledge-creating community” within the

company.

Healthywords goes part of the way toward explaining the

processes road-mapped in book’s Summary and Outlook section:

• How data becomes information, becomes knowledge • How issues of literacy have a bearing on the writing

of texts by corporate scientists• How these texts are to be fully understood and acted

upon by their assumed audiences/readers • How the same corporate scientists are to be trained as

collaborative corporate rhetors• How the company is itself constructed as a text to be

‘read’ in the competitive market.

To explicate how these different processes can be opti-

mized, the author has combined research on text usability,

commentary on postmodern research in text analysis, and

discussions of the medical writers’ place within their cor-

porate culture. The mixture of scholarly and applied infor-

mation, and the frequent switches between knowledge-ori-

ented and practice-oriented content, make Healthywordssomewhat less effective as a handbook (which should pro-

vide specific guidance for decision-making and problem-

solving) than it could be for managers. Readers must work

hard to find the author’s useful advice about writing better

documents that will satisfy patients’ needs and comply

with current regulatory requirements.

The book is nicely printed and attractively laid out, apart

from some gaps of white space after a few sections and

tables. The Acknowledgements, Preface and General

Introduction lead into four chapters that deal with working

practices within the pharmaceutical industry, rhetorical

considerations in the field of medical communication, col-

laborative environments in medical communication, and

the role of pharmaceutical industry managers’ training,

education, and social responsibility. The chapters and their

sections are clearly sign-posted, and the book concludes

with a Reference section and a Bibliography for those

interested in further reading. The typesetting reflects a

sometimes odd combination of English and non-English

conventions, but most readers would probably not be too

distracted by this.

Busy managers in highly competitive pharmaceutical and

communications industry environments could benefit from

the knowledge and insights compiled in this book—but

their information retrieval task would be made much easi-

er by a careful revision and restructuring of the text to

highlight the elements of practical guidance. Perhaps a sec-

ond, revised edition will allow Taylor’s valuable contribu-

tions to shine through the rest of the intriguing but less use-

ful content on postmodern rhetorical analysis.

Karen Shashok Translator—Editorial consultantGranada, Spain [email protected]

Call for contributionsTWS welcomes articles (800-2800 words) or boxes (up

to 800 words) on topics of interest to medical writers,

particularly on the future themes: ‘perception vs proof’

(where there is no evidence to support what is rightly or

wrongly accepted as fact) and titles (article titles or aca-

demic titles). Ideas for future themes are very much

appreciated as are letters commenting on anything you

have read in TWS or would like to say to or about

EMWA. Please submit to Elise at [email protected].

After attending a couple of EMWA conferences, I noticed

that a lot of medical writers share the same addiction—the

love for food (and wine of course). Good news is that we

are not the only ones. There are a lot of foodophiles (so

called “foodies”) around the globe who genuinely love

food, who love dining out, who love cooking, who get

excited about trying out new recipes etc. The perfect plat-

form to exchange your experiences with fellow foodies is

a food blog. The world of food blogs is as diverse as the

world of medical writing. You can easily explore the world

of food myths and cultures and eventually come across

new recipes.

Below you find a small selection of my favourite food

blogs from around the world. Visit the forums to chat about

food and to discuss recipes, restaurants, and everything

else with fellow food lovers. Join me in exploring new

culinary possibilities by getting inspirations from around

the world.

http://chocolateandzucchini.comChocolate & Zucchini: this blog is written by one of the

biggest stars in the food blogging community, Clotilde

Dusoulier, a Parisian who shares her passion for all things

food-related including thoughts, ideas, recipes, and restau-

rant experiences. She recently published her own cook book.

http://www.deliciousdays.comDelicious days: this food blog from a couple in Munich lets

you take a peek into their steamy kitchen. This blog reflects

the authors’ passions: Munich, the Bavarian city they live in,

their travel experiences, cookbook reviews and the pursuit of

all things delicious. Check out their mouth-watering recipes!

http://orangette.blogspot.comOrangette: a very addictive food-literature blog. This blog

of a Seattle-based foodie provides you with an interesting

collection of stories, often autobiographical and always

gastronomical. The fun-to-read stories are often accompa-

nied by recipes.

http://annesfood.blogspot.comAnne’s Food: this is a blog from a Swedish girl living in

Stockholm who is obsessed with food and cooking. Get the

latest recipes (in English or Swedish) and discover insider

tips for nice restaurants and bars in Stockholm.

http://brandoesq.blogspot.com Kuidaore—cooking & eating to surfeited collapse: thisSingaporean food blog provides an insight into the blog-ger’s obsession with macaroons and also provides you withtips to prepare high-level multi-course dinners.

http://nami-nami.blogspot.comNami-Nami: this blog of an Estonian foodie returning toher hometown Tallinn after living in Edinburgh for sevenyears is about cooking and eating in Estonia and beyond.The blogger shares recipes and insights to the Estonianway of living with us.

http://cupcakeblog.comCupcake Bakeshop: this San Francisco-based blog is abouta true obsession with cupcakes. Everything you ever want-ed to know about cupcakes (and how to bake them) butwere afraid to ask. Learn how to make the most incredibleand delicious cupcakes. Choose from an infinite number ofrecipes, from savoury to sweet.

Joeyn M. FlauausTrilogy Writing & Consulting GmbHFrankfurt am Main, [email protected]

Caution—foodieseverywhere!



Webscout:

by Joeyn Flauaus

If you find a page that should be mentioned in the

next issue, or if you have any other comments or

suggestions, please email me at:

[email protected].

Facilitating comprehension?• The laboratory facility was instructed to use the

new device from 1 September 2006 onwards.

• We have just opened up a new laboratory facility at

our Philadelphia site.

• The laboratory facility is staffed by 27 specialist

technicians.

Does facility actually add anything here?


Transparency of medical writingassistance and misleading compositeend points in clinical trials



91

Journal watch:

by Nancy Milligan

Transparency: the key to an ethicalrelationship between medical writers andjournalsIn an editorial recently published in the Journal of

Investigative Dermatology, a freelance medical writer and

the managing editor of the journal have come together to

continue the debate on the role of medical writers in bio-

medical publishing [1]. In the article, Heather Yarnell

Schultz and Elizabeth Blalock recognise the increasing use

of medical writers in biomedical publishing (apparently the

market for medical writers grows by about 15% each year

[2]) and examine the ethics of recognising writing assis-

tance in published material. They suggest that ‘the problem

is not with the use of medical writers per se, but the use of

unacknowledged medical writers or the use of medical

writers to prepare articles that list authors who have not

contributed to the intellectual process of the article’. They

also highlight the problem of authors concealing funding

sources for writing services. The authors go on to describe

the viewpoints of various organisations who have pub-

lished standards or guidelines for authorship and writing

assistance (the International Committee of Medical Journal

Editors [ICMJE; 3], the American and European Medicals

Writers Associations [AMWA and EMWA; 4, 5], and the

Pharmaceutical Research and Manufacturers of America

[6]). They conclude that it is generally accepted that most

medical writers would not qualify for full authorship, but

that medical writers should at least be acknowledged in the

manuscript and therefore that the role of any writing assis-

tance should be transparent. In response to the various

guidelines, the GATE principles were put forward by

Daskalopoulou and Mikhailidis to guide the ethical con-

duct of professional writers and authors [7]. GATE stands

for: guarantee (are the authors guarantors of the work?),

advice (did the authors advise the writer?), transparency (is

the writer acknowledged?), and expertise (did the writer

have sufficient expertise to draft the article?). Yarnell

Schultz and Blalock conclude that ‘clearly, transparency is

the key to a harmonious relationship between medical writ-

ers and the biomedical peer-reviewed journals’.

Encouragingly, the article finishes by putting forward

expectations of the Journal of Investigative Dermatology

for corresponding authors; they suggest that authors should

guarantee that: (1) authors in the by-line of submitted man-

uscripts meet ICMJE standards, (2) the contributions of

medical writers not meeting the ICMJE standards are stat-

ed in the acknowledgements, (3) the funding for such writ-

ers, either through employment or through other sources, is

stated in the acknowledgements, and (4) authors are will-

ing to take public responsibility for the scientific merit of

the published work. This type of guideline supports an ethi-

cal relationship between journals and medical writers, which

can only be a good thing for the future of our industry.

Problems with the use of composite endpoints in cardiovascular clinical trialsComposite end points, a method of combining multiple

single end points, are often used in cardiology clinical tri-

als to increase event rates and statistical power (a common

composite may consist of cardiovascular mortality,

myocardial infarction, and revascularisation outcomes).

However, composite end points can be misleading if one

component is overrepresented in the results, which can

lead to an overestimation of the impact of the treatment on

the other outcomes. A recent systematic review investigat-

ed the characteristics of composite end points in 114 car-

diovascular randomised controlled trials in six major jour-

nals [8]. The researchers were interested in the extent to

which the individual components of composite end points

varied in importance to patients (categorised as fatal, criti-

cal, major, moderate, and minor), the frequency of events

in more or less important components, and the extent of

variability in the relative risk reductions across compo-

nents. Reporting of composite end points was often inade-

quate. 68% of studies (n = 77) reported complete compo-

nent data for the primary composite end point, and 98% of

composite end points included fatal end points, usually ‘all

cause mortality’. 56% (n = 64) of composite end points

showed either a large (10%; n = 11) or moderate (47%;

n = 53) gradient in importance to patients. Of the 84 com-

posite end points that reported data for at least two of their

component end points, 45 (54%) of the component end

points showed large or moderate gradients in both impor-

tance to patients and the effect of treatment across compo-

nents. When analysed by categories of importance to

patients, less important components showed higher event

rates (with medians of 3.3% for both fatal and critical out-

comes, 3.7% for major outcomes, 12.3% for moderate out-

comes, and 8% for minor outcomes) and larger treatment

effects (relative risk reduction of 8% for death and 33% for

minor outcomes). For example, mortality outcomes pro-

vided the lowest event rates and showed the smallest treat-

ment effects even though they were present in most of the

cardiovascular composite end points. This study highlights



Journal watch:

the challenge medical writers face when writing up trials

that report composite end points. The main advice should

be to interpret composite results with caution to avoid

overestimating the treatment effect of certain outcomes,

and to ensure you report results for the separate compo-

nents, if available, as well as the overall results.

Nancy MilliganDianthus Medical [email protected]

References:

1. Yarnall Schultz H, Blalock E. Transparency is the key to the relationship

between biomedical journals and medical writers. J Invest Dermatol2007;127:735–7.

2. Korieth K. Medical writing market appreciation. CenterWatch 2004;11:1–5.

3. International Committee of Medical Journal Editors. Uniform requirements for

manuscripts submitted to biomedical journals: writing and editing for biomed-

ical publication, updated February 2006. Available at: http://www.

icmje.org/index.html

4. Hamilton CW, Royer MG. AMWA position statement on the contributions of

medical writers to scientific publications. AMWA J 2003;18:13–16.

5. Jacobs A, Wager E. European Medical Writers Association (EMWA) guide-

lines on the role of medical writers in developing peer-reviewed publications.

Curr Med Res Opin 2005;21:317–22.

6. Pharmaceutical Research and Manufacturers of America Principles on conduct

of clinical trials and communication of clinical trial results, 2002. Available at:

http://www.phrma.org/files/Clinical%20Trials.pdf

7. Daskalopoulou SS, Mikhailidis DP. The involvement of professional medical

writers in medical publications. Curr Med Res Opin 2005;21:307–10.

8. Ferreira-González I, Busse JW, Heels-Ansdell D, et al. Problems with use of

composite end points in cardiovascular trials: systematic review of randomised

controlled trials. BMJ 2007;334(7597):786–92.

UK vs US spelling pitfallsYou knew that UK spelling requires ‘programme’, not

‘program’, for ‘conference programme’ and most other

usages, but did you know that according to the ConciseOxford Dictionary, ‘program’ is usually the preferred

spelling for ‘computer program’?

The preferred spelling of the element S is ‘sulfur’ with

an ef in both US and UK spelling. IUPAC adopted the

spelling ‘sulfur’ in 1990, as did the Royal Society of

Chemistry Nomenclature Committee in 1992

(http://en.wikipedia.org/wiki/Sulfur). But the journal

Nature is not alone in continuing to uphold British cus-

tom by spelling it ‘sulphur’. Googling on ‘sulfur

spelling’ brings up 161 thousand hits, and googling on

‘sulphur spelling’ finds 267 thousand.

Doctor Moroneh of Edinburgh is a practising endocri-

nologist with a private practice who needs to practise his

golf swing. His colleague Doctor Tolisembam of

Chicago is a practicing endocrinologist with a private

practice who needs to practice his baseball swing.


Pharmaceutical industry publishing practices ofclinical trial results: The ‘PPP’ SurveyThere is an increasing demand for greater transparency inthe publication of clinical trial results because trust in thepharmaceutical industry is low. Little research on publish-ing processes in the pharmaceutical industry is available. Inthe course of research being conducted by HelenaKorjonen-Close at University College London School ofLibrary, Archive and Information Studies (UCL SLAIS), asurvey will to be launched on the UCL SLAIS website(http://www.ucl.ac.uk/slais/research/) in September 2007.The survey will target medical writers and marketing peo-ple involved in publishing processes in the pharmaceuticalindustry and its service agencies (clinical research organi-sations and medical communications agencies).

The aim of the survey is to

• identify current methods of dissemination of clinical

trial results

• identify how those involved in disseminating results

understand the new methods in publishing, including

open access and requirements of biomedical journals

when submitting articles

• explore how the selection is made on what results are

disseminated and why

• explore the pharmaceutical industry’s understanding of

its reputation and transparency

• understand how a journal is selected when wishing to publish

• find out the importance of timeliness of the dissemina-

tion of results; early release vs end of trial.

UCL SLAIS is a leading centre for research in librarianship,information science, archives and records management, espe-cially in the areas of health informatics, research evaluation,and scholarly communication.

Helena [email protected]

Why I don’t like using ‘using’ Version 1: Identifying active transcription factors andkinases from expression data using pathway queries

Do the data use pathway queries, or do human beings usethe queries?

Version 2: Identifying active transcription factors andkinases from expression data-using pathway queries

Now it’s the queries which use expression data. But is thatwhat the authors meant?

Version 3: Identifying active transcription factors andkinases from expression data by using pathway queries

That’s better–clear and unequivocal. But why not say ‘withpathway queries’? Or ‘Using pathway queries to identifyactive transcription factors and kinases from expression data’?



TheWrite Stuff

nadnaslov> > >

Alistair ReevesIf in doubt, leave them out—or maybe not? 53

Valerie A. EllistonCommas 58

Richard ClarkThe fatal comma 61

Mary Ellen KeransGertrude Stein on degrading commas in the prose alas 63

Ursula SchoenbergUsing some comman sense 64

Kathy B. Thomas and Claudia TeschClinical Trial Disclosure: The ongoing debate on public registers for clinical trials 67

Kari SkinningsrudSaving a brain drain: The Norwegian-Russian Centre for Medical Studies and a medical writer’s role in grant applications 73

Jonathan McFarlandTeaching English to the medical professionDeveloping communication skills and bringing humanities to medicine 75

Alison McIntoshReading round your therapeutic area 77

Samina HamiltonA personal account of my first year as a freelance medical writer 79

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The CommaVol 16, No. 2, 2007

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